CN112654308A - Force indicating retractor device and method of use - Google Patents

Abstract

Devices, systems, and methods for measuring forces applied to a joint during a surgical procedure are disclosed. The device includes an insertion tool, a handle, and one or more force indicators. The insertion tool includes an insertion end and a base end. The one or more force indicators may be attached to the insertion tool and the handle. The insertion end of the device may be inserted into a joint during a surgical procedure and used to apply force to the joint and/or to measure force using one or more force indicators when applying force.

Description

Force indicating retractor device and method of use

Priority declaration

Us provisional application No. 62/715,576 entitled "FORCE indicating retraction device and method OF USE" filed on 7.8.2018, us-INDICATING RETRACTOR DEVICE AND METHODS OF USE, us provisional application No. 62/792,246 entitled "FORCE indicating retraction device and method OF USE" filed on 14.1.2019, us-INDICATING RETRACTOR DEVICE AND METHODS OF USE "filed on 7.5.2019, us-62/844,451 entitled" field-INDICATING RETRACTOR DEVICE AND METHODS OF USE "filed on 7.5.2019, each OF which is incorporated herein by reference in its entirety.

Technical Field

The present disclosure relates generally to methods, systems, and devices related to computer-assisted surgery systems including various hardware and software components that work together to enhance surgical workflow. The disclosed techniques may be applied to, for example, shoulder, hip, and knee arthroplasty, as well as other surgical procedures, such as arthroscopic procedures, spinal procedures, maxillofacial procedures, rotator cuff procedures, and ligament repair and replacement procedures.

Background

The use of computers, robots and imaging to assist bone surgery is known in the art. There has been a great deal of research and development on computer-aided navigation and robotic systems used to guide surgical procedures. For example, surgical navigation systems can help surgeons locate patient anatomy, guide surgical instruments, and implant medical devices with high accuracy. Surgical navigation systems typically employ various forms of computing technology to perform various standard and minimally invasive surgical procedures and techniques. In addition, these systems allow surgeons to more accurately plan, track and navigate the placement of instruments and implants relative to the patient's body, as well as perform pre-operative and intra-operative body imaging.

Orthopedic implants are used to remodel surfaces (resurfacing) or replace joints, such as the knee, hip, shoulder, ankle, and elbow, which typically experience high levels of stress and wear or trauma. The implants used to replace these joints must be strong and able to withstand everyday stresses and wear at these joints, particularly for weighted knee and hip joint replacements. However, providing an implant that is strong enough and a proper fit is challenging. Conventional orthopedic implants are made of polymers, ceramics, metals, or other suitable materials and are formed such that they fit securely to the patient's bone. For example, in knee replacement surgery, a typical method involves cutting the end of the tibia and/or femur and then installing a new implant to the cut end. The size of the implant is typically determined by the surgeon based on hand measurements and visual estimations. The size and fit between the bone and the implant may differ-in some cases the size and fit may be too loose, while in other cases the size and fit may be too tight.

Robotically-assisted Total Knee Arthroplasty (TKA) provides a user with the ability to plan an implant surgical procedure and view the desired outcome prior to performing a bone resection. In order to perform virtual planning, information on two physiological aspects of the patient's knee is required. Specifically, the virtual planning system requires (1) anatomical information about the femur and tibia of the patient, and (2) information about soft tissue tension/laxity within the joint. Obtaining information about the femur and tibia of a patient (i.e., bone anatomy) can be reliably performed in a number of ways, whether pre-operatively or intra-operatively. However, the characteristics of the surrounding soft tissue are less objective. Lack of objectivity in the primary system input may lead to inconsistent results.

During robot-assisted TKA, the user may be provided with indications of varus and valgus stresses as the knee moves through a range of motion. For example, the graphical user interface may display such measurements to assist the surgeon in performing TKA surgery. Identifying varus/valgus stress helps quantify the laxity of the various ligaments and other soft tissues within the knee. However, stresses are typically applied manually or via a z-shaped retractor placed between the medial and lateral tibial-femoral articular surfaces of the knee. Therefore, quantifying ligament laxity in such procedures is challenging because the magnitude of varus/valgus forces applied to the knee are not standardized.

Accordingly, there is a need for devices and methods for the acquisition of soft tissue tension and/or relaxation information in standardized joints (e.g., the knee).

Disclosure of Invention

An apparatus for use during a surgical procedure is provided. The device includes a tissue retractor, a handle, and one or more force indicators. The tissue retractor includes an insertion end and a base end. The insertion end of the tissue retractor is configured to be inserted between articulating surfaces of a joint of a patient. The base end of the tissue retractor is attached to the handle. The handle is configured to facilitate a user applying a force to the device, thereby distracting the joint when the insertion end of the tissue retractor is inserted between the femoral articular surface and the tibial articular surface of the patient's knee.

According to some embodiments, the articular surfaces of the patient's joint are femoral and tibial articular surfaces of the patient's knee. In some embodiments, the insertion end is configured to be inserted between a condyle of a femur and a corresponding condyle of a tibia of a patient's knee. In some embodiments, the insertion end is configured to be inserted between both condyles of a femur and corresponding both condyles of a tibia of a patient's knee.

According to certain embodiments, the one or more force indicators are in electronic communication with the robotic surgical system. This electrical communication may be wired or wireless.

According to some embodiments, the device includes a display in electronic communication with the one or more force indicators. In certain embodiments, the display is a digital display.

According to some embodiments, the device comprises one or more location tracking devices. In certain embodiments, the position tracking device is an optical tracking array. In certain embodiments, the one or more position tracking devices are in electronic communication with the robotic surgical system.

According to some embodiments, the apparatus comprises a power cord. According to some embodiments, the apparatus comprises a wireless power supply. The wireless power source may include a stationary battery, a removable battery, a fluctuating magnetic field, a photovoltaic array, or any combination thereof.

According to some embodiments, the one or more force indicators comprise one or more strain gauges in the base end of the tissue retractor. The tissue retractor also includes a pivot feature positioned adjacent to one or more strain gauges in the base end of the tissue retractor and configured to concentrate stress generated by a user applying force to the device at the handle when an insertion end of the tissue retractor is inserted between articular surfaces of the patient's joint at the location of the one or more strain gauges. One or more strain gauges included in the base end of the tissue retractor measure the resulting stress when a user applies force to the device at the handle. The distraction force can be estimated by using the stress measured by one or more strain gauges included in the base end of the tissue retractor, and by assuming the location of the point of contact between the articular surface of the patient's joint and the insertion end of the tissue retractor when the user applies a force to the device at the handle. According to certain embodiments, the one or more strain gauges include digital strain gauges.

According to certain embodiments, the one or more force indicators comprise one or more pressure sensors located in the insertion end of the tissue retractor. The one or more surface pressure sensors are configured to measure a pressure generated when a user applies a force to the device at the handle when the insertion end of the tissue retractor is inserted between articulating surfaces of a patient's joint. When a user applies a force to the device at the handle, the distracting force is estimated by using the stress measured by the one or more pressure sensors included on the insertion end of the tissue retractor and by the known location of the contact point between the articular surface of the patient's joint and the insertion end of the tissue retractor. According to certain embodiments, the one or more surface pressure sensors comprise piezoelectric effect sensors.

According to certain embodiments, the device additionally includes one or more components of the tissue retractor each having an insertion end and a base end, and one or more handles disposed about the rotational joint. A rotational spring is wound around the rotational joint. The one or more force indicators comprise one or more electrical contact sensors or magnetic contact sensors. When the insertion end of each of the one or more components of the tissue retractor is inserted between the articulating surfaces of the patient's joint and a user applies a force to the one or more handles, the one or more components of the tissue retractor pivot about the rotational joint until the rotational spring reaches a displacement point that reaches a predetermined torque. One or more electrical or magnetic sensors may be triggered when the handle reaches a point of displacement that reaches a predetermined torque. According to certain embodiments, the one or more electrical or magnetic contact sensors comprise piezoelectric effect sensors, hall effect sensors, inductive sensors, micro-electromechanical system (MEMS) sensors, piezoresistive sensors, load sensors, ultrasonic resonators in combination with compressible propagating structures, capacitive sensors, and/or temperature sensors.

According to certain embodiments, when a desired distraction force or displacement point is achieved, the robotic surgical system generates a signal to trigger acquisition of position data from one or more position sensors located on the patient's tibia and/or femur.

According to certain embodiments, the robotic surgical system generates an alarm when a desired distraction force or displacement point is reached. The alarm may be visual, audible or tactile.

A method of measuring a force applied to a joint using a surgical device is also provided. The method includes attaching a plurality of position tracking devices to a portion of a patient's body, inserting the devices into a portion of a joint, applying a force to a portion of the devices, and measuring the force applied to the devices. In certain embodiments, the position tracking device is an optical tracking array. In certain embodiments, the device comprises a tissue retractor, a handle, and one or more force indicators. The tissue retractor includes an insertion end and a base end. The insertion end of the tissue retractor is configured to be inserted between a femoral surface and a tibial surface of a knee of a patient. The base end of the tissue retractor is attached to the handle. The handle is configured to facilitate application of a force to a portion of the body.

In an alternative embodiment, the method includes attaching a plurality of position tracking devices to a portion of a patient's body, inserting the devices into a portion of a joint, bending the joint, and measuring a force applied to the devices.

According to some embodiments, a plurality of position tracking devices attached to a portion of a patient's body are attached to the patient's tibia and femur. In certain embodiments, a plurality of position tracking devices are in electronic communication with the robotic surgical system. In certain embodiments, the electronic communication is wireless.

According to certain embodiments, each of the one or more force indicators is in electronic communication with the robotic surgical system. In certain embodiments, the electronic communication is wireless.

According to some embodiments, the device further comprises one or more position tracking devices in electronic communication with the robotic surgical system. In certain embodiments, the position tracking device is an optical tracking array. In some embodiments, the electronic communication may be wireless.

In certain embodiments, position data from one or more position tracking devices attached to the device is used to determine the directionality of the force applied by the user to the patient's body using the device. In certain embodiments, the directional nature of the force applied to the patient's body by the user using the device is used to determine the kinematics of a portion of the patient's body when the user applies different amounts of force.

According to certain embodiments, data from a plurality of position tracking devices attached to a patient body part is used to capture the position of the patient body part when the device is inserted into the joint part and a force is applied to the patient body part. In certain embodiments, data from a plurality of position tracking devices attached to a patient's body part is used to capture the position of the femur and tibia as the devices are inserted into the articular portion and force is applied to the patient's body part. In some embodiments, the position of the femur and tibia is captured by a robotic surgical system. In some embodiments, the position of the femur and tibia is used to determine the flexion angle of the femur and tibia when the device is inserted into the articular portion and a force is applied to the patient's body portion. In certain embodiments, data from a plurality of position tracking devices attached to a patient body part is used to capture the flexion angles of the femur and tibia as the devices are inserted into the articular portion and apply forces to the patient body part. In certain embodiments, the flexion angle is captured by a robotic surgical system.

Drawings

The accompanying drawings, which are incorporated in and form a part of this specification, illustrate embodiments of the present disclosure and, together with the written description, serve to explain the principles, features, and characteristics of the disclosure. In the drawings:

fig. 1 depicts an operating room including an illustrative Computer Assisted Surgery System (CASS) according to an embodiment.

FIG. 2A depicts illustrative control instructions provided by a surgical computer to other components of a CASS, according to an embodiment.

FIG. 2B depicts illustrative control instructions provided by components of a CASS to a surgical computer, according to an embodiment.

Fig. 2C depicts an illustrative implementation of a surgical computer connected to a surgical data server over a network, according to an embodiment.

Fig. 3 depicts a surgical patient care system and an illustrative data source according to an embodiment.

Fig. 4A depicts an illustrative flow diagram for determining a preoperative surgical plan, according to an embodiment.

Fig. 4B depicts an illustrative flow diagram for determining a episode of care including pre-operative, intra-operative, and post-operative actions in accordance with an embodiment.

Fig. 4C depicts an illustrative graphical user interface including an image depicting implant placement, in accordance with an embodiment.

Fig. 5A depicts a perspective view of a device according to an embodiment.

Fig. 5B depicts a perspective view of an alternative device according to an embodiment.

Fig. 5C depicts a perspective view of an alternative device according to an embodiment.

Fig. 5D depicts a transparent perspective view of the alternative device of fig. 5C, in accordance with embodiments.

Fig. 5E depicts a second transparent perspective view of the alternative device of fig. 5C, in accordance with embodiments.

Fig. 5F depicts a top view of an alternative device according to an embodiment.

Fig. 6A depicts a perspective view of an alternative device according to an embodiment.

Fig. 6B depicts another perspective view of an alternative device according to an embodiment.

Fig. 6C depicts a side view of an alternative apparatus according to an embodiment.

Fig. 6D depicts a top view of an alternative device according to an embodiment.

Fig. 7A depicts a perspective view of a device inserted into a knee of a patient, according to an embodiment.

Fig. 7B depicts a front view of a device inserted into a knee of a patient, according to an embodiment.

Fig. 8A depicts a perspective view of a device having a modifiable tip, in accordance with an embodiment.

Fig. 8B depicts a perspective view of an alternative device with a modifiable tip, in accordance with an embodiment.

Fig. 8C depicts a perspective view of an alternative device with a modifiable tip, in accordance with an embodiment.

Fig. 9 depicts an illustrative flow diagram for measuring forces applied to a joint during a surgical procedure, according to an embodiment.

Fig. 10A depicts another illustrative flow diagram for measuring forces applied to a joint during a surgical procedure, in accordance with an embodiment.

Fig. 10B depicts another illustrative flow diagram for measuring forces applied to a joint during a surgical procedure, in accordance with an embodiment.

Fig. 11 depicts a perspective view of another device according to an embodiment.

Fig. 12 depicts a perspective view of the device of fig. 11 inserted into a knee of a patient, according to an embodiment.

Fig. 13 depicts a side view of the device of fig. 11, according to an embodiment.

Fig. 14 depicts a perspective view of another device according to an embodiment.

Fig. 15 depicts an illustrative flow diagram for measuring forces applied to a joint during a surgical procedure, according to an embodiment.

FIG. 16 depicts an illustrative block diagram of a data processing system in which aspects of the illustrative embodiments may be implemented.

Detailed Description

The present disclosure is not limited to the particular systems, devices, and methods described, as these systems may vary. The terminology used in the description is for the purpose of describing the particular versions or embodiments only and is not intended to limit the scope.

As used in this document, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Nothing in this disclosure should be construed as an admission that the embodiments described in this disclosure are not entitled to antedate such disclosure by virtue of prior invention. As used in this document, the term "including" means "including but not limited to".

Definition of

For the purposes of this disclosure, the term "implant" is used to refer to a prosthetic device or structure that is manufactured to replace or augment a biological structure. For example, in total hip replacement surgery, prosthetic acetabular cups (implants) are used to replace or augment worn or damaged acetabulum of a patient. Although the term "implant" is generally considered to refer to an artificial structure (as opposed to an implant), for purposes of this specification, an implant may include biological tissue or material that is implanted to replace or augment a biological structure.

For purposes of this disclosure, the term "real-time" is used to refer to calculations or operations that are performed on the fly as events occur or as input is received by the surgical system. However, the use of the term "real-time" is not intended to exclude operations that cause some delay between input and response, as long as the delay is an unintended consequence of the performance characteristics of the machine.

Although much of the disclosure relates to surgeons or other medical personnel in a particular title or role, nothing in this disclosure is intended to be limited to a particular title or function. The surgeon or medical personnel may include any doctor, nurse, medical personnel, or technician. Any of these terms or titles may be used interchangeably with a user of the system disclosed herein, unless explicitly defined otherwise. For example, in some embodiments, reference to a surgeon may also apply to a technician or nurse.

Overview of CASS ecosystem

Fig. 1 provides an illustration of an exemplary Computer Assisted Surgery System (CASS)100, in accordance with some embodiments. As described in further detail in the following sections, CASS uses computers, robotics, and imaging techniques to assist surgeons in performing orthopedic surgical procedures, such as Total Knee Arthroplasty (TKA) or Total Hip Arthroplasty (THA). For example, surgical navigation systems can help surgeons locate patient anatomy, guide surgical instruments, and implant medical devices with high accuracy. Surgical navigation systems such as the CASS 100 typically employ various forms of computing technology to perform various standard and minimally invasive surgical procedures and techniques. In addition, these systems allow surgeons to more accurately plan, track and navigate the placement of instruments and implants relative to the patient's body, as well as perform pre-operative and intra-operative body imaging.

The effector platform 105 positions a surgical tool relative to a patient during surgery. The exact components of the actuator platform 105 will vary depending on the embodiment employed. For example, for knee surgery, the effector platform 105 may include an end effector 105B that holds a surgical tool or instrument during its use. End effector 105B may be a hand-held device or instrument used by a surgeon (e.g.,

a handpiece or cutting guide or clamp), or alternatively, the end effector 105B may comprise a device or instrument held or positioned by the robotic arm 105A.

The effector platform 105 may include a limb positioner 105C for positioning a limb of a patient during a procedure. One example of a limb locator 105C is the SMITH AND NEPHEW SPIDER2 system. Limb positioner 105C may be operated manually by the surgeon, or alternatively change limb position based on instructions received from surgical computer 150 (described below).

The ablation device 110 (not shown in fig. 1) performs bone or tissue ablation using, for example, mechanical, ultrasonic, or laser techniques. Examples of ablation apparatus 110 include drilling devices, deburring devices, vibratory sawing devices, vibratory impacting devices, reamers, ultrasonic bone cutting devices, radio frequency ablation devices, and laser ablation systems. In some embodiments, the resection device 110 is held and operated by the surgeon during the procedure. In other embodiments, the effector platform 105 may be used to hold the resection device 110 during use.

The effector platform 105 may also include a cutting guide or clamp 105D for guiding a saw or drill used to resect tissue during surgery. Such a cut guide 105D may be integrally formed as part of the effector platform 105 or robotic arm 105A, or the cut guide may be a separate structure that may be matingly and/or removably attached to the effector platform 105 or robotic arm 105A. The effector platform 105 or robotic arm 105A may be controlled by the CASS 100 to position the cutting guide or clamp 105D near the patient's anatomy according to a pre-or intra-operatively developed surgical plan so that the cutting guide or clamp will produce a precise bone cut according to the surgical plan.

The tracking system 115 uses one or more sensors to acquire real-time position data that locates the patient's anatomy and surgical instruments. For example, for TKA surgery, the tracking system may provide the position and orientation of the end effector 105B during operation. In addition to positioning data, data from the tracking system 115 may also be used to infer velocity/acceleration of the anatomy/instrument, which may be used for tool control. In some embodiments, the tracking system 115 may determine the position and orientation of the end effector 105B using an array of trackers attached to the end effector 105B. The position of the end effector 105B may be inferred based on the position and orientation of the tracking system 115 and a known relationship in three-dimensional space between the tracking system 115 and the end effector 105B. Various types of tracking systems may be used in various embodiments of the present invention, including but not limited to Infrared (IR) tracking systems, Electromagnetic (EM) tracking systems, video or image based tracking systems, and ultrasound registration tracking systems.

Any suitable tracking system may be used to track the surgical object and patient anatomy in the operating room. For example, a combination of IR and visible light cameras may be used in the array. Various illumination sources, such as IR LED light sources, may illuminate the scene, allowing three-dimensional imaging. In some embodiments, this may include stereoscopic imaging, tri-view (tri-view) imaging, quad-view (quad-view) imaging, and the like. In addition to the camera array being attached to the cart in some embodiments, additional cameras may be placed throughout the operating room. For example, a handheld tool or headset worn by the operator/surgeon may include imaging capabilities that communicate images back to the central processor to associate these images with the images captured by the camera array. This may give a more robust image for an environment modeled using multiple perspectives. Further, some imaging devices may have a suitable resolution or a suitable perspective to the scene to pick up information stored in a Quick Response (QR) code or barcode. This may help identify particular objects that are not manually registered with the system.

In some embodiments, a particular object may be manually registered in the system by a surgeon pre-or intra-operatively. For example, by interacting with the user interface, the surgeon may identify the starting location of the tool or bone structure. By tracking fiducial markers associated with the tool or bone structure, or by using other conventional image tracking modes, the processor can track the tool or bone in the three-dimensional model as it moves through the environment.

In some embodiments, certain markers, such as fiducial markers that identify individuals, critical tools, or bones in the operating room, may include passive or active identifiers that can be picked up by a camera or camera array associated with the tracking system. For example, an IR LED may flash a pattern, communicating a unique identifier to the source of the pattern, thereby providing a dynamic identification indicia. Similarly, one-or two-dimensional optical codes (barcodes, QR codes, etc.) may be attached to objects in the operating room to provide passive identification that may occur based on image analysis. If these codes are placed asymmetrically on the object, they can also be used to determine the orientation of the object by comparing the position of the identifier with the range of the object in the image. For example, the QR code may be placed in a corner of the tool tray, allowing tracking of the orientation and features of the tray. Other tracking modes are explained elsewhere herein. For example, in some embodiments, surgeons and other staff may wear augmented reality headsets to provide additional camera angle and tracking capabilities.

In addition to optical tracking, certain features of an object, such as fiducial markers fixed to a tool or bone, may be tracked by recording physical characteristics of the object and correlating them to the object that may be tracked. For example, a surgeon may perform a manual registration process whereby the tracked tool and the tracked bone may be manipulated relative to each other. By impacting the tip of the tool against the surface of the bone, a three-dimensional surface can be mapped against the bone, the three-dimensional surface being associated with a position and orientation of the reference frame relative to the fiducial marker. By optically tracking the position and orientation (pose) of fiducial markers associated with the bone, a model of the surface can be tracked with the environment by extrapolation.

The registration process to register the CASS 100 with the relevant anatomy of the patient may also involve the use of anatomical landmarks, such as landmarks on bone or cartilage. For example, the CASS 100 may include a 3D model of the relevant bone or joint, and the surgeon may intraoperatively acquire data regarding the positioning of bone markers on the patient's actual bone using a probe connected to the CASS. Bone landmarks may include, for example, the medial and lateral prisms, the proximal femur and the distal tibia, and the center of the hip joint. The CASS 100 may compare and register the position data of a bone landmark acquired by a surgeon with a probe with the position data of the same landmark in a 3D model. Alternatively, the CASS 100 may construct a 3D model of a bone or joint without preoperative image data by using bone markers and position data of the bone surface acquired by the surgeon using a CASS probe or other means. The registration process may also include determining various axes of the joint. For example, for TKA, the surgeon may use the CASS 100 to determine the anatomical and mechanical axes of the femur and tibia. The surgeon and CASS 100 may identify the center of the hip joint by moving the patient's leg in a spiral direction (i.e., circular), so that the CASS can determine where the center of the hip joint is located.

The tissue navigation system 120 (not shown in fig. 1) provides the surgeon with intraoperative real-time visualization of bone, cartilage, muscle, nerve and/or vascular tissue of the patient surrounding the surgical field. Examples of systems that may be used for tissue navigation include fluoroscopic imaging systems and ultrasound systems.

Display 125 provides a Graphical User Interface (GUI) that displays images acquired by tissue navigation system 120, as well as other information related to the procedure. For example, in one embodiment, the display 125 overlays image information acquired from various modalities (e.g., CT, MRI, X-ray, fluoroscopic, ultrasound, etc.), pre-or intra-operatively, to provide the surgeon with various views of the patient's anatomy and real-time conditions. The display 125 may include, for example, one or more computer monitors. Instead of or in addition to the display 125, one or more members of the surgical staff may wear an Augmented Reality (AR) Head Mounted Device (HMD). For example, in fig. 1, surgeon 111 is wearing AR HMD 155, which may overlay pre-operative image data or provide surgical planning recommendations, e.g., on a patient. Various exemplary uses of AR HMD 155 in surgical procedures are detailed in the following sections.

Surgical computer 150 provides control instructions to the various components of the CASS 100, collects data from those components, and provides general processing for the various data required during the procedure. In some embodiments, surgical computer 150 is a general purpose computer. In other embodiments, surgical computer 150 may be a parallel computing platform that performs processing using multiple Central Processing Units (CPUs) or Graphics Processing Units (GPUs). In some embodiments, surgical computer 150 is connected to a remote server via one or more computer networks (e.g., the internet). For example, a remote server may be used to store data or perform computationally intensive processing tasks.

Various techniques generally known in the art may be used to connect surgical computer 150 to the other components of CASS 100. In addition, the computer may be connected to surgical computer 150 using a mix of technologies. For example, end effector 105B may be connected to surgical computer 150 by a wired (i.e., serial) connection. Tracking system 115, tissue navigation system 120, and display 125 may similarly be connected to surgical computer 150 using wired connections. Alternatively, the tracking system 115, tissue navigation system 120, and display 125 may be connected to the surgical computer 150 using wireless technology, such as, but not limited to, Wi-Fi, bluetooth, Near Field Communication (NFC), or ZigBee.

Electric percussion and acetabular reamer device

Part of the flexibility of the CASS design described above with respect to fig. 1 is that additional or alternative devices may be added to the CASS 100 as needed to support a particular surgical procedure. For example, in the context of hip surgery, the CASS 100 may include a powered impacting device. The impacting device is designed to repeatedly apply impact forces that the surgeon can use to perform activities such as implant alignment. For example, in Total Hip Arthroplasty (THA), a surgeon will often use an impacting device to insert a prosthetic acetabular cup into the acetabulum of an implant host. While the impacting device may be manual in nature (e.g., operated by a surgeon impacting an impactor with a hammer), it is generally easier and faster to use a powered impacting device in a surgical environment. For example, a battery attached to the device may be used to power the electric percussion device. Various attachments may be connected to the powered impacting device to allow the impact force to be directed in various ways as desired during the procedure. Also in the context of hip surgery, the CASS 100 may include a motorized robotically controlled end effector for reaming the acetabulum to accommodate an acetabular cup implant.

In robot-assisted THA, the anatomy of a patient may be registered to the CASS 100 using CT or other image data, identification of anatomical landmarks, a tracker array attached to the patient's anatomy, and one or more cameras. The tracker array may be mounted on the intestinal spine using clamps and/or bone pins, and such trackers may be mounted externally through the skin, or internally (postero-lateral or antero-lateral) through an incision made for THA. For THA, the CASS 100 may assist the registration process with one or more femoral cortical screws inserted into the proximal femur as checkpoints. The CASS 100 may also utilize one or more checkpoint screws inserted into the pelvis as additional checkpoints to assist in the registration process. The femoral tracker array may be fixed to or mounted in a femoral cortical screw. The CASS 100 may employ the step of verifying registration using a probe that the surgeon accurately places on critical areas of the proximal femur and pelvis identified for the surgeon on the display 125. A tracker may be located on the robotic arm 105A or end effector 105B to register the arm and/or end effector with the CASS 100. The verification step may also utilize proximal and distal femoral checkpoints. The CASS 100 may utilize color or other cues to inform the surgeon that the relevant bone and registration process of the robotic arm 105A or end effector 105B have been verified to some degree of accuracy (e.g., within 1 mm).

For THA, the CASS 100 may include a broach tracking option using a femoral array to allow the surgeon to capture broach position and orientation intra-operatively and calculate hip length and offset values for the patient. Based on the information provided about the patient's hip joint and the planned implant position and orientation after the broach tracking is completed, the surgeon may make modifications or adjustments to the surgical plan.

For robot-assisted THA, the CASS 100 may include one or more motorized reamers connected or attached to a robotic arm 105A or end effector 105B that prepares the pelvis to receive the acetabular implant according to a surgical plan. The robotic arm 105A and/or end effector 105B may notify the surgeon and/or control the power of the reamer to ensure that the acetabulum is being resected (reamed) according to the surgical plan. For example, if the surgeon attempts to resect bone outside of the bone boundary according to the surgical plan, the CASS 100 may close the reamer or instruct the surgeon to close the reamer. The CASS 100 may provide the surgeon with the option of closing or releasing the robotic control of the reamer. The display 125 may depict the progression of the resected (reamed) bone compared to the surgical plan using different colors. The surgeon may view a display of the bone being resected (reamed) to guide the reamer through reaming according to the surgical plan. The CASS 100 may provide visual or audible cues to the surgeon to alert the surgeon that an ablation is being performed that does not conform to the surgical plan.

After reaming, the CASS 100 may employ a manual or powered impactor attached or connected to the robotic arm 105A or end effector 105B to impact the trial implant and final implant into the acetabulum. The robotic arm 105A and/or end effector 105B may be used to guide an impactor to impact the trial implant and the final implant into the acetabulum according to a surgical plan. The CASS 100 can display the position and orientation of the trial implant and the final implant relative to the bone to inform the surgeon as to the orientation and position of the trial implant and the final implant as compared to the surgical plan, and the display 125 can display the position and orientation of the implant as the surgeon manipulates the legs and hip joint. If the surgeon is not satisfied with the original implant position and orientation, the CASS 100 may provide the surgeon with the option to re-plan and re-ream and implant impacting by preparing a new surgical plan.

Preoperatively, the CASS 100 may develop the proposed surgical plan based on a three-dimensional model of the hip joint and other patient-specific information, such as the mechanical and anatomical axes of the leg bones, the epicondylar axis, the femoral neck axis, the size (e.g., length) of the femur and hip joint, the midline axis of the hip joint, the ASIS axis of the hip joint, and the location of anatomical landmarks, such as the lesser trochanter landmark, the distal landmark, and the center of rotation of the hip joint. The surgical plan developed by the CASS may provide recommended optimal implant sizes and implant positions and orientations based on three-dimensional models of the hip joint and other information specific to the patient. The surgical plan developed by the CASS may include suggested details regarding offset values, lean and anteversion values, center of rotation, cup size, median value, superior-inferior fit values, femoral stem size, and length.

For THA, the surgical plan developed by CASS can be viewed preoperatively and intraoperatively, and the surgeon can modify the surgical plan developed by CASS preoperatively or intraoperatively. The surgical plan developed by the CASS may show a planned resection of the hip joint and superimpose the planned implant on the hip joint based on the planned resection. The CASS 100 may provide the surgeon with options for different surgical workflows that are presented to the surgeon based on the surgeon's preferences. For example, the surgeon may select from different workflows based on the number and type of anatomical landmarks examined and captured and/or the location and number of tracker arrays used in the registration process.

According to some embodiments, the electric impact device used with the CASS 100 may operate in a variety of different settings. In some embodiments, the surgeon adjusts the settings by a manual switch or other physical mechanism on the power impact device. In other embodiments, a digital interface may be used that allows for input to be set, for example, via a touch screen on the power impact device. Such a digital interface may allow for the available settings to be changed based on, for example, the type of attachment connected to the electrically powered attachment device. In some embodiments, rather than adjusting settings on the electric impact device itself, the settings may be changed by communicating with a robot or other computer system within the CASS 100. Such a connection may be established using, for example, a bluetooth or Wi-Fi network module on the power impact device. In another embodiment, the impacting device and end pieces may contain features that allow the impacting device to know which end piece (cup impactor, broach shank, etc.) to attach without the need for surgeon action, and adjust the settings accordingly. This may be achieved, for example, by QR codes, bar codes, RFID tags, or other methods.

Examples of settings that may be used include cup impact settings (e.g., single direction, specified frequency range, specified force and/or energy range); broach impact settings (e.g., bi-directional/oscillatory at a specified frequency range, specified force and/or energy range); femoral head impact settings (e.g., single directional/single blow at a specified force or energy); and shank impact settings (e.g., unidirectional with a specified frequency at a specified force or energy). Additionally, in some embodiments, the powered impacting device includes provisions related to impacting (e.g., single directional/single blow at a specified force or energy) the acetabular liner. There may be multiple arrangements of each type of liner, such as a polymeric material, a ceramic material, a blackish crystal material, or other materials. Further, the powered impacting device may provide settings for different bone qualities based on preoperative testing/imaging/knowledge and/or intraoperative assessment by the surgeon.

In some embodiments, the motorized impacting device includes a feedback sensor that collects data during use of the instrument and sends the data to a computing device, such as a controller within the device or surgical computer 150. The computing device may then record the data for later analysis and use. Examples of data that may be acquired include, but are not limited to, sound waves, predetermined resonance frequencies for each instrument, reaction or rebound energy from a patient's bone, the position of the device relative to the bone anatomy registered for imaging (e.g., fluorescence, CT, ultrasound, MRI, etc.), and/or external strain gauges on the bone.

Once the data is acquired, the computing device may execute one or more algorithms in real-time or near real-time to assist the surgeon in performing the surgical procedure. For example, in some embodiments, the computing device uses the collected data to derive information, such as the appropriate final broach size (femur); time when the stem is fully seated (femoral side); or the time the cup is in place (depth and/or orientation) for THA. Once the information is known, it may be displayed for viewing by the surgeon, or it may be used to activate a tactile or other feedback mechanism to guide the surgical procedure.

In addition, data derived from the aforementioned algorithms may be used to drive the operation of the device. For example, during insertion of a prosthetic acetabular cup with an electric impacting device, once the implant is fully seated, the device may automatically extend an impact head (e.g., an end effector) to move the implant into position, or turn off the device power supply. In one embodiment, the derived information can be used to automatically adjust the setting of bone mass, where the motorized impacting device should use less power to mitigate femoral/acetabular/pelvic fractures or damage to surrounding tissue.

Mechanical arm

In some embodiments, the CASS 100 includes a robotic arm 105A that serves as an interface for stabilizing and holding various instruments used during a surgical procedure. For example, in the context of hip surgery, these instruments may include, but are not limited to, retractors, sagittal or reciprocating saws, reamer handles, cup impactors, broach shanks, and stem inserters. The robotic arm 105A may have multiple degrees of freedom (e.g., spider device) and may have the ability to lock into place (e.g., by pressing a button, voice activation, the surgeon removing a hand from the robotic arm, or other methods).

In some embodiments, the movement of the robotic arm 105A may be accomplished through the use of a control panel built into the robotic arm system. For example, the display screen may include one or more input sources, such as physical buttons or a user interface with one or more icons, that direct movement of the robotic arm 105A. A surgeon or other medical personnel may engage one or more input sources to position the robotic arm 105A while performing a surgical procedure.

The tool or end effector 105B attached or integrated into the robotic arm 105A may include, but is not limited to, a deburring device, a scalpel, a cutting device, a retractor, a joint tensioning device, and the like. In embodiments using the end effector 105B, the end effector may be positioned at the end of the robot arm 105A such that any motor controlled operation is performed within the robot arm system. In embodiments using a tool, the tool may be fixed at the distal end of the robotic arm 105A, but the motor control operations may reside within the tool itself.

The robotic arm 105A may be maneuvered internally to stabilize the robotic arm, preventing it from falling and hitting a patient, operating table, surgical staff, etc., and to allow the surgeon to move the robotic arm without having to fully support its weight. As the surgeon moves the robotic arm 105A, the robotic arm may provide some resistance to prevent the robotic arm from moving too fast or activating too many degrees of freedom at once. The position and lock status of the robotic arm 105A may be tracked, for example, by the controller or surgical computer 150.

In some embodiments, the robotic arm 105A may be moved manually (e.g., by a surgeon) or using an internal motor to its desired position and orientation for the task being performed. In some embodiments, the robotic arm 105A may be enabled to operate in a "free" mode that allows the surgeon to position the arm in a desired position without restriction. When in free mode, the position and orientation of the robotic arm 105A may still be tracked as described above. In one embodiment, certain degrees of freedom may be selectively released upon user (e.g., surgeon) input during a designated portion of the surgical plan tracked by the surgical computer 150. Designs in which the robotic arm 105A is internally powered by hydraulics or motors or by similar means to provide resistance to external manual movement may be described as an electro-robotic arm, while arms that are manually manipulated without power feedback but may be locked into place manually or automatically may be described as passive robotic arms.

The robotic arm 105A or end effector 105B may include a trigger or other device for controlling the power of the saw or drill. The surgeon engaging a trigger or other device may transition the robotic arm 105A or end effector 105B from a motorized alignment mode to a saw or drill engagement and energization mode. Additionally, the CASS 100 may include a foot pedal (not shown) that causes the system to perform certain functions when activated. For example, the surgeon may activate a foot pedal to instruct the CASS 100 to place the robotic arm 105A or end effector 105B into an automated mode that places the robotic arm or end effector in the appropriate position relative to the patient's anatomy in order to perform the necessary resection. The CASS 100 may also place the robotic arm 105A or end effector 105B in a cooperative mode that allows a surgeon to manually manipulate and position the robotic arm or end effector in a particular location. The cooperation mode may be configured to allow the surgeon to move the robotic arm 105A or end effector 105B in the medial or lateral directions while limiting movement in other directions. As discussed, the robotic arm 105A or end effector 105B may include a cutting device (saw, drill, and burr) or a cutting guide or clamp 105D that will guide the cutting device. In other embodiments, the movement of the robotic arm 105A or robotically-controlled end effector 105B may be controlled entirely by the CASS 100 without any or minimal assistance or input from the surgeon or other medical personnel. In still other embodiments, movement of the robotic arm 105A or robotically-controlled end effector 105B may be controlled remotely by a surgeon or other medical personnel using a control mechanism separate from the robotic arm or robotically-controlled end effector apparatus, such as using a joystick or an interactive monitor or display control device.

The following example describes the use of the robotic device in the context of hip surgery; however, it should be understood that the robotic arm may have other applications for surgical procedures involving the knee, shoulder, etc. One example of the use of Robotic arms in the context of creating an Anterior Cruciate Ligament (ACL) Graft tunnel is described in U.S. provisional patent application No. 62/723,898 entitled "Robotic Assisted Ligament Graft Placement and organizing," filed on 28.8.2018, which is incorporated herein by reference in its entirety.

The robotic arm 105A may be used to hold a retractor. For example, in one embodiment, the robotic arm 105A may be moved to a desired location by a surgeon. At this point, the robotic arm 105A may be locked into place. In some embodiments, the robotic arm 105A is provided with data regarding the patient's position so that if the patient moves, the robotic arm can adjust the retractor position accordingly. In some embodiments, multiple robotic arms may be used, thereby allowing multiple retractors to be held or perform more than one activity simultaneously (e.g., retractor holding and reaming).

The robotic arm 105A may also be used to help stabilize the surgeon's hand while making the femoral neck cut. In this application, the control of the robotic arm 105A may impose certain restrictions to prevent soft tissue damage from occurring. For example, in one embodiment, the surgical computer 150 tracks the position of the robotic arm 105A as it operates. If the tracked location is close to the area of predicted tissue damage, a command may be sent to the robotic arm 105A to stop it. Alternatively, where the robotic arm 105A is automatically controlled by the surgical computer 150, the surgical computer may ensure that the robotic arm is not provided any instructions to enter the area where soft tissue damage may occur. Surgical computer 150 can impose certain restrictions on the surgeon to prevent the surgeon from reaming too far or at an incorrect angle or orientation in the medial wall of the acetabulum.

In some embodiments, the robotic arm 105A may be used to hold the cup impactor at a desired angle or orientation during cup impact. When the final position has been reached, the robotic arm 105A may prevent any further reaming to prevent damage to the pelvis.

The surgeon may use the robotic arm 105A to position the broach shank in a desired position and allow the surgeon to strike the broach into the femoral canal at a desired orientation. In some embodiments, once the surgical computer 150 receives feedback that the broach is fully seated, the robotic arm 105A may restrain the handle to prevent further advancement of the broach.

The robotic arm 105A may also be used for resurfacing applications. For example, the robotic arm 105A may stabilize the surgeon while using conventional instruments and provide certain limitations or constraints to allow proper placement of the implant components (e.g., guidewire placement, chamfer cutters, sleeve cutters, planning cutters, etc.). Where only a burr is employed, the robotic arm 105A may stabilize the surgeon's hand piece and may impose restrictions on the hand piece to prevent the surgeon from removing unintended bone in violation of the surgical plan.

Surgical procedure data generation and acquisition

The various services provided by medical personnel to treat clinical conditions are collectively referred to as "episodes of care". For a particular surgical procedure, the episode of care (epicode of care) may include three phases: before, during and after surgery. During each stage, data is collected or generated that can be used to analyze the episode of care in order to understand aspects of the procedure and to identify patterns that can be used, for example, to train decisions in the model with minimal human intervention. The data collected in the care segment may be stored in the surgical computer 150 or the surgical data server 180 as a complete data set. Thus, for each episode of care, there is a data set that includes all data on the patient, collectively referred to as preoperative, all data acquired or stored by the CASS 100 intraoperatively, and any post-operative data provided by the patient or by medical personnel monitoring the patient.

As explained in further detail, data acquired during the episode of care can be used to enhance the performance of the surgical procedure or provide an overall understanding of the surgical procedure and patient outcome. For example, in some embodiments, data collected in a episode of care may be used to generate a surgical plan. In one embodiment, the high level preoperative plan is refined intraoperatively as data is acquired during the operation. In this manner, the surgical plan may be viewed as dynamically changing in real-time or near real-time as the components of the CASS 100 acquire new data. In other embodiments, preoperative images or other input data may be used to develop a stabilization plan preoperatively that is only performed during surgery. In this case, data acquired by the CASS 100 during surgery may be used to make recommendations to ensure that the surgeon remains within the pre-operative surgical plan. For example, if the surgeon is not certain how to achieve a particular prescribed cut or implant alignment, the surgical computer 150 can be queried for recommendations. In still other embodiments, the preoperative and intraoperative planning methods may be combined such that a robust preoperative plan may be dynamically modified as needed or desired during the surgical procedure. In some embodiments, the biomechanically based model of the patient's anatomy provides simulation data for consideration by the CASS 100 in developing pre-operative, intra-operative, and post-operative/rehabilitation procedures to optimize the patient's implant performance results.

In addition to changing the surgical procedure itself, the data collected during the episode of care may be used as input for other surgical assistance procedures. For example, in some embodiments, the implant may be designed using the care segment data. Exemplary data driven techniques for designing, sizing, and installing Implants are described in U.S. patent application No. 13/814,531 entitled "Systems and Methods for Optimizing Parameters for orthopaedics Procedures", filed on 15.2011, U.S. patent application No. 14/232,958 entitled "Systems and Methods for Optimizing Fit of an Implant to an atom", filed on 20.2012, and U.S. patent application No. 12/234,444 entitled "Optimizing Implants for incorporated Performance", filed on 19.9.2008, each of which is incorporated herein by reference in its entirety.

Furthermore, the data may be used for educational, training or research purposes. For example, using the web-based approach described below in fig. 2C, other physicians or students may remotely view the procedure in an interface that allows them to selectively view data collected from the various components of the CASS 100. After a surgical procedure, a similar interface may be used to "playback" the procedure for training or other educational purposes, or to determine the source of any problems or complications in the procedure.

The data acquired during the pre-operative phase typically includes all information acquired or generated prior to the procedure. Thus, for example, information about the patient may be obtained from a patient intake table or an Electronic Medical Record (EMR). Examples of patient information that may be collected include, but are not limited to, patient demographics, diagnosis, medical history, progress notes, vital signs, medical history information, allergies, and laboratory results. The preoperative data may also include images relating to anatomical regions of interest. These images may be captured, for example, using Magnetic Resonance Imaging (MRI), Computed Tomography (CT), X-ray, ultrasound, or any other modality known in the art. The pre-operative data may also include quality of life data captured from the patient. For example, in one embodiment, a pre-operative patient uses a mobile application ("app") to answer questionnaires regarding their current quality of life. In some embodiments, the preoperative data used by the CASS 100 includes demographic, anthropometric, cultural, or other specific characteristics about the patient that may be consistent with activity levels and specific patient activities to customize the surgical plan for the patient. For example, certain cultures or demographics may be more likely to use toilets that require squatting every day.

Fig. 2A and 2B provide examples of data that may be acquired during the intraoperative phase of a episode of care. These examples are based on the various components of the CASS 100 described above with reference to fig. 1; however, it should be understood that other types of data may be used based on the type of device used during the procedure and its use.

Figure 2A illustrates an example of some control instructions provided by the surgical computer 150 to other components of the CASS 100, according to some embodiments. Note that the example of FIG. 2A assumes that the components of the effector platform 105 are each directly controlled by the surgical computer 150. In embodiments where the components are manually controlled by surgeon 111, instructions may be provided on display 125 or AR HMD 155 instructing surgeon 111 how to move the components.

The various components included in the effector platform 105 are controlled by a surgical computer 150 that provides position commands that indicate which movement of the components within the coordinate system is to be made. In some embodiments, the surgical computer 150 provides instructions to the effector platform 105 that define how to react when components of the effector platform 105 deviate from a surgical plan. These commands are referred to in fig. 2A as "haptic" commands. For example, the end effector 105B may provide a force that resists movement outside of the area of planned resection. Other commands that may be used by the actuator platform 105 include vibration and audio prompts.

In some embodiments, the end effector 105B of the robotic arm 105A is operatively coupled with the cutting guide 105D. In response to the anatomical model of the surgical scene, the robotic arm 105A may move the end effector 105B and the cut guide 105D into the appropriate position to match the position of the femoral or tibial cut performed according to the surgical plan. This may reduce the likelihood of error, allowing the vision system and a processor utilizing the vision system to implement a surgical plan to place the cutting guide 105D at a precise location and orientation relative to the tibia or femur to align the cutting slot of the cutting guide with a cut performed according to the surgical plan. The surgeon may then use any suitable tool, such as an oscillating or rotating saw or drill, to perform the cut (or drill) with perfect placement and orientation, as the tool is mechanically constrained by the features of the cutting guide 105D. In some embodiments, the cutting guide 105D may include one or more pin holes used by the surgeon to drill holes or screw or pin the cutting guide into place prior to using the cutting guide to perform resection of patient tissue. This may release the robotic arm 105A or ensure that the cutting guide 105D is fully fixed from moving relative to the bone to be resected. For example, this procedure may be used to make a first distal cut of the femur during a total knee arthroplasty. In some embodiments where the arthroplasty is a hip arthroplasty, the cutting guide 105D may be secured to a femoral head or acetabulum for a corresponding hip arthroplasty resection. It should be understood that any arthroplasty utilizing a precise cut may use the robotic arm 105A and/or the cutting guide 105D in this manner.

The resection device 110 is equipped with various commands for performing bone or tissue procedures. As with the effector platform 105, positioning information may be provided to the ablation device 110 to specify where it should be when performing an ablation. Other commands provided to the ablation device 110 may depend on the type of ablation device. For example, for a mechanical or ultrasonic ablation tool, the commands may specify the speed and frequency of the tool. For Radio Frequency Ablation (RFA) and other laser ablation tools, the commands may specify intensity and pulse duration.

Certain components of the CASS 100 need not be controlled directly by the surgical computer 150; rather, the surgical computer 150 need only activate the components, which then execute the software locally, specify the manner in which the data is collected, and provide it to the surgical computer 150. In the example of fig. 2A, two components are operated in this manner: a tracking system 115 and an organization navigation system 120.

The surgical computer 150 provides any visualization required by the surgeon 111 during the procedure to the display 125. For a monitor, surgical computer 150 may provide instructions for displaying images, GUIs, etc. using techniques known in the art. The display 125 may include various aspects of the workflow of the surgical plan. For example, during the registration process, the display 125 may display a preoperatively constructed 3D bone model and depict the position of the probe as it is used by the surgeon to acquire the position of anatomical landmarks on the patient. The display 125 may include information about the surgical target area. For example, in conjunction with TKA, the display 125 may depict the mechanical and anatomic axes of the femur and tibia. The display 125 may depict the varus and valgus angles of the knee joint based on the surgical plan, and the CASS 100 may depict how the envisaged modifications to the surgical plan would affect these angles. Thus, the display 125 is an interactive interface that can dynamically update and display how changes in the surgical plan will affect the surgery and the final position and orientation of the implant mounted on the bone.

When the workflow progresses to prepare for a bone cut or resection, the display 125 may depict a planned or recommended bone cut before performing any cuts. The surgeon 111 may manipulate the image display to provide different anatomical perspectives of the target region, and may have the option of changing or modifying the planned bone cut based on the patient's intraoperative assessment. The display 125 may depict how the selected implant would fit on the bone if the planned bone cut were performed. If the surgeon 111 chooses to change a previously planned bone cut, the display 125 may depict how the modified bone cut will change the position and orientation of the implant when installed on the bone.

The display 125 may provide the surgeon 111 with various data and information about the patient, the planned surgery, and the implant. Various patient-specific information may be displayed, including real-time data about the patient's health, such as heart rate, blood pressure, and the like. The display 125 may also include information about the anatomy of the surgical target area, including the location of landmarks, the current state of the anatomy (e.g., whether any resections have been made, the depth and angle of the planned and performed bone cuts), and the future state of the anatomy as the surgical plan progresses. The display 125 may also provide or depict additional information about the surgical target area. For TKA, the display 125 may provide information about the gaps (e.g., gap balance) between the femur and tibia and how these gaps would change if the planned surgical plan were performed. For TKA, the display 125 may provide other relevant information about the knee joint, such as data about joint tension (e.g., ligament slack) and information about the rotation and alignment of the joint. The display 125 may depict how the planned implant positioning and position will affect the patient as the knee is flexed. The display 125 can depict how the use of different implants or different sizes of the same implant will affect the surgical plan and preview how these implants will be positioned on the bone. The CASS 100 may provide such information for each planned bone resection in TKA or THA. In TKA, the CASS 100 may provide robotic control for one or more of the planned bone resections. For example, the CASS 100 may provide robotic control for only the initial distal femoral cut, and the surgeon 111 may manually perform other resections (anterior, posterior, and chamfer cuts) using conventional means, such as a 4-in-1 cut guide or jig 105D.

The display 125 may take different colors to inform the surgeon of the status of the surgical plan. For example, non-resected bone may be displayed in a first color, resected bone may be displayed in a second color, and a planned resection may be displayed in a third color. The implant may be superimposed on the bone in the display 125, and the implant color may vary or may correspond to different types or sizes of implants.

The information and options depicted on the display 125 may vary depending on the type of surgical procedure being performed. In addition, the surgeon 111 may request or select a particular surgical workflow display that matches or is consistent with its surgical plan preferences. For example, for a surgeon 111 who typically performs a tibial cut prior to a femoral cut in TKA, the display 125 and associated workflow may be adapted to account for this preference. The surgeon 111 may also pre-select certain steps to include or delete from the standard surgical workflow display. For example, if the surgeon 111 uses the resection measurements to finalize the implant plan, but does not analyze ligament gap balance when finalizing the implant plan, the surgical workflow display may be organized into modules, and the surgeon may select the modules to display and the order in which the modules are provided based on the surgeon's preferences or the circumstances of the particular procedure. For example, modules for ligament and gap balancing may include pre-resection/post-resection ligament/gap balancing, and the surgeon 111 may select which modules to include in their default surgical plan workflow depending on whether they perform such ligament and gap balancing before or after bone resection.

For more specialized display devices, such as AR HMDs, surgical computer 150 may provide images, text, etc. using data formats supported by the device. For example, if the display 125 is a holographic device, such as Microsoft HoloLensTM or Magic Leap OneTM, the surgical computer 150 may send commands using the HoloLens Application Program Interface (API) specifying the location and content of the holograms displayed in the field of view of the surgeon 111.

In some embodiments, one or more surgical planning models may be incorporated into the CASS 100 and used to develop the surgical plan provided to the surgeon 111. The term "surgical planning model" refers to software that models biomechanical properties of an anatomical structure in various contexts to determine the best way to perform cutting and other surgical activities. For example, for knee replacement surgery, the surgical planning model may measure parameters of functional activity, such as knee deep flexion, gait, etc., and select a cutting location on the knee to optimize implant placement. One example of a surgical planning model is LIFEMOD from SMITH AND NEPHEW, INC^TMAnd (5) simulating software. In some embodiments, the surgical computer 150 includes a computing architecture that allows the surgical planning model to be fully executed during surgery (e.g., a GPU-based parallel processing environment). In other embodiments, the surgical computer 150 may be connected over a network to a remote computer that allows this to occur, such as a surgical data server 180 (see FIG. 2C). As an alternative to fully executing the surgical planning model, in some embodiments, a set of transfer functions is derived that reduce the mathematical operations captured by the model to one or more prediction equations. Then, instead of performing a complete simulation during surgery, predictive equations are used. Further details regarding the use of transfer functions are described in U.S. provisional patent application No. 62/719415 entitled "Patient Specific Surgical Method and System," which is incorporated herein by reference in its entirety.

FIG. 2B shows an example of some of the data types that may be provided from various components of CASS 100 to surgical computer 150. In some embodiments, the component may transmit the data stream to the surgical computer 150 in real-time or near real-time during the procedure. In other embodiments, the component may arrange the data and send it to the surgical computer 150 at set intervals (e.g., every second). The data may be transmitted using any format known in the art. Thus, in some embodiments, the components all transmit data to surgical computer 150 in a common format. In other embodiments, each component may use a different data format, and the surgical computer 150 is configured with one or more software applications that enable data interpretation.

Generally, the surgical computer 150 may serve as a central point for acquiring CASS data. The exact content of the data will vary depending on the source. For example, each component of the effector platform 105 provides a measured position to the surgical computer 150. Thus, by comparing the measured position to the position originally specified by the surgical computer 150 (see FIG. 2B), the surgical computer can identify deviations that occurred during the procedure.

Depending on the type of device used, the ablation device 110 can send various types of data to the surgical computer 150. Example types of data that may be transmitted include measured torque, audio signatures, and measured displacement values. Similarly, the tracking technique 115 may provide different types of data depending on the tracking method employed. Exemplary tracking data types include location values of tracked items (e.g., anatomy, tool, etc.), ultrasound images, and surface or landmark acquisition points or axes. When the system is in operation, tissue navigation system 120 provides anatomical locations, shapes, etc. to surgical computer 150.

Although a display 125 is typically used to output data for presentation to the user, the display can also provide data to the surgical computer 150. For example, for embodiments using a monitor as part of the display 125, the surgeon 111 may interact with the GUI to provide input that is sent to the surgical computer 150 for further processing. For AR applications, the measured HMD position and displacement may be sent to the surgical computer 150 so that it can update the rendered views as needed.

During the post-operative phase of the episode of care, various types of data may be collected to quantify the overall improvement or worsening of the patient's condition due to the surgery. The data may take the form of self-reported information, for example, reported by the patient via a questionnaire. For example, in the context of Knee arthroplasty, functional status may be measured with the Oxford Knee Score questionnaire, and postoperative quality of life may be measured with the EQ5D-5L questionnaire. Other examples in the context of Hip arthroplasty may include Oxford Hip Score, Harris Hip Score, and WOMAC (Western Ontario and McMaster university osteoarthritic index). For example, such questionnaires may be administered directly by medical personnel in a clinical setting or using a mobile app that allows the patient to answer questions directly. In some embodiments, a patient may be equipped with one or more wearable devices that acquire data related to a procedure. For example, after knee surgery, the patient may be equipped with a knee brace that includes sensors that monitor knee positioning, flexibility, and the like. This information can be collected and transmitted to the patient's mobile device for review by the surgeon to assess the surgical outcome and resolve any issues. In some embodiments, one or more cameras may capture and record the motion of a body segment of a patient during a post-operative prescribed activity. This motion capture can be compared to a biomechanical model to better understand the function of the patient's joint, to better predict the progress of recovery, and to identify any possible revision that may be needed.

The post-operative phase of the episode of care may last the entire life of the patient. For example, in some embodiments, the surgical computer 150 or other components comprising the CASS 100 may continue to receive and collect data related to the surgical procedure after the operation has been performed. These data may include, for example, images, answers to questions, "normal" patient data (e.g., blood type, blood pressure, pathology, medication, etc.), biometric data (e.g., gait, etc.), and objective and subjective data about specific questions (e.g., knee or hip pain). This data may be explicitly provided to surgical computer 150 or other CASS component by the patient or the patient's physician. Alternatively or additionally, the surgical computer 150 or other CASS component can monitor the patient's EMR and retrieve relevant information when available. This longitudinal view of the patient recovery allows the surgical computer 150 or other CASS component to provide a more objective analysis of the patient's results to measure and track the success or lack of success of a given procedure. For example, the condition experienced by a patient long after a surgical procedure can be traced back to the surgery through regression analysis of various data items collected during the episode of care. Such analysis may be further enhanced by analyzing groups of patients undergoing similar procedures and/or having similar anatomical structures.

In some embodiments, data is collected at a central location to provide easier analysis and use. In some cases, data may be collected manually from various CASS components. For example, a portable storage device (e.g., a USB stick) may be attached to the surgical computer 150 to retrieve data collected during surgery. The data may then be transferred to a central storage device, for example, by a desktop computer. Alternatively, in some embodiments, surgical computer 150 is directly connected to a central storage device via network 175, as shown in fig. 2C.

Fig. 2C illustrates a "cloud-based" embodiment in which surgical computer 150 is connected to surgical data server 180 via network 175. This network 175 may be, for example, a private intranet or the internet. In addition to data from surgical computer 150, other sources may transmit relevant data to surgical data server 180. The example of fig. 2C shows 3 additional data sources: a patient 160, medical personnel 165, and an EMR database 170. Thus, the patient 160 may send pre-operative and post-operative data to the surgical data server 180, for example, using a mobile application. Medical personnel 165 include surgeons and their staff, as well as any other professionals (e.g., private doctors, health professionals, etc.) working with the patient 160. It should also be noted that the EMR database 170 may be used for pre-operative and post-operative data. For example, the surgical data server 180 may collect the patient's pre-operative EMR, provided that sufficient rights have been given to the patient 160. The surgical data server 180 may then continue to monitor the EMR to see any updates after surgery.

At the surgical data server 180, a care segment database 185 is used to store various data collected on the patient's care segments. The care segment database 185 may be implemented using any technique known in the art. For example, in some embodiments, an SQL-based database may be used in which all of the various data items are constructed in a manner that allows them to be easily incorporated into two SQL row and column sets. However, in other embodiments, a No-SQL database may be used to allow unstructured data while providing the ability to quickly process and respond to queries. As understood in the art, the term "No-SQL" is used to define a class of data stores that are non-relational in their design. Various types of No-SQL databases can be grouped generally according to their underlying data model. These groupings can include databases that use a column-based data model (e.g., Cassandra), a document-based data model (e.g., MongoDB), a key-value-based data model (e.g., Redis), and/or a graph-based data model (e.g., Allego). Any type of No-SQL database may be used to implement the various embodiments described herein, and in some embodiments, different types of databases may support the care segment database 185.

Data may be transmitted between the various data sources and surgical data server 180 using any data format and transmission techniques known in the art. It should be noted that the architecture shown in fig. 2C allows for transmission from a data source to the surgical data server 180, as well as retrieval of data from the surgical data server 180 by the data source. For example, as explained in detail below, in some embodiments, the surgical computer 150 can use data from past surgeries, machine learning models, and the like to help guide the surgical procedure.

In some embodiments, the surgical computer 150 or surgical data server 180 may perform a de-identification process to ensure that the data stored in the care segment database 185 meets the Health Insurance Portability and Accountability Act (HIPAA) standards or other requirements set by law. HIPAA provides a list of certain identifiers that must be deleted from the data during de-recognition. The aforementioned de-identification process may scan these identifiers in data that is transmitted to the care segment database 185 for storage. For example, in one embodiment, prior to initiating the transmission of a particular data item or set of data items to surgical data server 180, surgical computer 150 performs a de-recognition procedure. In some embodiments, a unique identifier is assigned to data from a particular episode of care to allow re-identification of the data if necessary.

Although fig. 2A-2C discuss data acquisition in the context of a single episode of care, it should be understood that the general concepts may be extended to data acquired from multiple episodes of care. For example, each time a procedure is performed with the CASS 100 and stored at the procedure computer 150 or procedure data server 180, procedure data may be collected throughout the care segment. As explained in further detail below, a database of robust episode of care data allows for the generation of optimized values, measurements, distances or other parameters, as well as other recommendations related to surgical procedures. In some embodiments, the various data sets are indexed in a database or other storage medium in a manner that allows for rapid retrieval of relevant information during a surgical procedure. For example, in one embodiment, a patient-centric set of indices may be used so that data relating to a particular patient or a group of patients similar to the particular patient may be easily extracted. The concept can be similarly applied to surgeons, implant features, CASS component versions, and the like.

Further details of the management of Care segment data are described in U.S. patent application No. 62/783,858 entitled "Methods and Systems for Providing Care segments" filed on 21/12/2018, which is incorporated herein by reference in its entirety.

Open and closed digital ecosystem

In some embodiments, the CASS 100 is designed to operate as a stand-alone or "closed" digital ecosystem. Each component of the CASS 100 is specifically designed for use in a closed ecosystem, and data is typically not accessible by devices other than a digital ecosystem. For example, in some embodiments, each component includes software or firmware that implements a proprietary protocol for activities such as communication, storage, security, and the like. The concept of a closed digital ecosystem may be desirable for companies that wish to control all of the components of the CASS 100 to ensure that certain compatibility, security, and reliability standards are met. For example, the CASS 100 may be designed such that new components cannot be used with the CASS unless certified by a company.

In other embodiments, the CASS 100 is designed to operate as an "open" digital ecosystem. In these embodiments, the components may be produced by a variety of different companies according to standards for activities such as communication, storage, and security. Thus, by using these standards, any company is free to build the stand-alone, compliant components of the CASS platform. Data may be transferred between components using publicly available Application Programming Interfaces (APIs) and open, sharable data formats.

To illustrate one type of recommendation that may be performed with the CASS 100, techniques for optimizing surgical parameters are disclosed below. In this context, the term "optimization" means the selection of the best parameters based on some specified criteria. In the extreme, optimization may refer to selecting the best parameters based on data from the entire episode of care, including any pre-operative data, the status of the CASS data at a given point in time, and post-operative goals. Further, the optimization may be performed using historical data, such as data generated during past procedures involving, for example, the same surgeon, past patients with similar physical characteristics to the current patient, and so forth.

The optimization parameters may depend on the portion of the patient's anatomy to be subjected to surgery. For example, for knee surgery, the surgical parameters may include positioning information for the femoral and tibial components, including but not limited to rotational alignment (e.g., varus/valgus rotation, supination, flexion rotation of the femoral component, posterior slope of the tibial component), resection depth (e.g., genu varus, genu valgus), and implant type, size, and position. The positioning information may also include surgical parameters for the modular implant, such as total limb alignment, combined tibial femoral hyperextension, and combined tibial femoral resection. Additional examples of parameters that may be optimized by the CASS 100 for a given TKA femoral implant include the following:

additional examples of parameters that may be optimized by the CASS 100 for a given TKA tibial implant include the following:

for hip surgery, the surgical parameters may include femoral neck resection position and angle, cup inclination angle, cup anteversion angle, cup depth, femoral stem design, femoral stem size, femoral stem fit within the canal, femoral offset, leg length, and femoral form of the implant.

The shoulder parameters may include, but are not limited to, humeral resection depth/angle, humeral stem form, humeral offset, glenoid form and inclination, and reverse shoulder parameters such as humeral resection depth/angle, humeral stem form, glenoid inclination/form, glenosphere orientation, glenosphere offset and offset direction.

Various conventional techniques exist for optimizing surgical parameters. However, these techniques are often computationally intensive and, therefore, often require the parameters to be determined preoperatively. Thus, the surgeon's ability to modify the optimized parameters based on problems that may arise during the procedure is limited. Furthermore, conventional optimization techniques typically operate in a "black box" manner with little or no explanation as to recommended parameter values. Thus, if the surgeon decides to deviate from the recommended parameter values, the surgeon typically does so without fully understanding the impact of the deviation on the rest of the surgical workflow, or the impact of the deviation on the quality of life of the patient after surgery.

Surgical patient care system

The general concept of optimization can be extended to the entire episode of care using a surgical patient care system 320 that uses surgical data, as well as other data from the patient 305 and medical personnel 330, to optimize outcomes and patient satisfaction, as depicted in fig. 3.

Conventionally, preoperative diagnosis of total joint arthroplasty, preoperative surgical planning, prescribed intraoperative performance and postoperative management are based on individual experience, published literature and a training knowledge base of surgeons (ultimately, tribal knowledge and journal publications for each surgeon and his peer "network"), and their instincts of accurate intraoperative tactile discrimination and accurate manual performance of planectomy for "balancing" using guides and visual cues. This prior knowledge base and implementation is limited in terms of the optimization of results provided to patients in need of care. For example, there are limitations with respect to: accurately diagnosing a patient for proper, minimally invasive prescription care; to reconcile dynamic patient, healthcare economy and surgeon preferences with patient desired outcomes; performing surgical planning to produce proper bone alignment and balance, etc.; and receiving data from disconnected sources with different biases that are difficult to coordinate to the overall patient frame. Thus, a data driven tool that more accurately simulates the anatomic response and guides the surgical plan may improve upon existing approaches.

The surgical patient care system 320 is designed to utilize patient specific data, surgeon data, healthcare facility data, and historical outcome data to develop algorithms that suggest or recommend an optimal overall treatment plan for the entire episode of care (pre, surgical, and post-operative) of the patient based on the desired clinical outcome. For example, in one embodiment, the surgical patient care system 320 tracks adherence to suggested or recommended plans and adjusts the plans based on patient/care provider performance. Once the surgical treatment plan is complete, the acquired data is recorded in a historical database by the surgical patient care system 320. The database is accessible to future patients and can be used to develop future treatment plans. Except using statistical sumsIn addition to learning models, simulation tools (e.g. for teaching models)

) Can be used to simulate outcomes, alignments, kinematics, etc. based on the preliminary or suggested surgical plan and reconfigure the preliminary or suggested plan to achieve the desired or optimal outcome according to the patient profile or the surgeon's preferences. The surgical patient care system 320 ensures that each patient receives individualized surgical and rehabilitation care, thereby increasing the chances of clinical outcome success and reducing the economic burden on recently renovated related facilities.

In some embodiments, the surgical patient care system 320 employs data acquisition and management methods to provide a detailed surgical case plan with different steps monitored and/or performed using the CASS 100. The user's profile is calculated at the completion of each step and can be used to suggest changes to subsequent steps of the case plan. Case plan generation relies on a series of input data stored locally or on a cloud storage database. The input data may be related to both current patient receiving treatment and historical data for patients receiving similar treatment.

The patient 305 provides input to a surgical patient care system 320, such as current patient data 310 and historical patient data 315. Various methods generally known in the art may be used to acquire such input from the patient 305. For example, in some embodiments, the patient 305 fills out a paper or digital survey that is parsed by the surgical patient care system 320 to extract patient data. In other embodiments, the surgical patient care system 320 can extract patient data from existing information sources, such as Electronic Medical Records (EMRs), health history files, and payer/provider history files. In still other embodiments, the surgical patient care system 320 may provide an Application Program Interface (API) that allows external data sources to push data to the surgical patient care system. For example, the patient 305 may cause a cell phone, wearable device, or other mobile device to collect data (e.g., heart rate, degree of pain or discomfort, level of motion or activity, or answers submitted by the patient that the patient is complying with any number of pre-operative planning criteria or conditions) and provide the data to the surgical patient care system 320. Similarly, the patient 305 may have a digital application on their mobile or wearable device that enables data to be collected and transmitted to the surgical patient care system 320.

The current patient data 310 may include, but is not limited to: activity level, pre-existing conditions, complications, repair performance, health and fitness level, pre-operative desired level (related to hospital, surgery, and recovery), Metropolitan Statistical Area (MSA) driven score, genetic background, past injuries (sports, trauma, etc.), previous arthroplasty, previous trauma surgery, previous sports medical surgery, treatment of contralateral joints or limbs, gait or biomechanical information (back and ankle problems), degree of pain or discomfort, care infrastructure information (payor coverage type, home healthcare infrastructure level, etc.), and an indication of the expected ideal outcome of the procedure.

The historical patient data 315 may include, but is not limited to: activity level, pre-existing conditions, complications, recovery performance, health and fitness level, pre-operative desired level (associated with hospital, surgery, and recovery), MSA driven score, genetic background, past injuries (sports, trauma, etc.), previous arthroplasty, previous trauma surgery, previous sports medical surgery, treatment of contralateral joints or limbs, gait or biomechanical information (back and ankle problems), degree or pain or discomfort, care infrastructure information (payer coverage type, home healthcare infrastructure level, etc.), expected ideal outcome of surgery, actual outcome of surgery (patient reported outcome [ PRO ], survival rate of implant, degree of pain, activity level, etc.), size of implant used, position/orientation/alignment of implant used, soft tissue balance achieved, etc.

Medical personnel 330 performing an operation or treatment may provide various types of data 325 to the surgical patient care system 320. This medical personnel data 325 may include: for example, surgical techniques (e.g., cross-retention (CR) versus Posterior Stabilization (PS), upscaling and downscaling, tourniquets versus tourniquets, femoral stem types, preferred methods of THA, etc.), training levels of the medical personnel 330 (e.g., years of practice, qualification for training, place of training, techniques that emulate who), previous success levels including historical data (outcomes, patient satisfaction), and expected ideal outcomes with respect to range of motion, number of days of recovery, and survival rates of the device are known or preferred. The medical staff data 325 can be captured, for example, by providing paper or digital surveys to the medical staff 330, by medical staff input to a mobile application, or by extracting relevant data from the EMR. Additionally, the CASS 100 may provide data describing the use of CASS during surgery, such as profile data (e.g., patient-specific knee instrument profiles) or historical logs.

Information about the facility in which the operation or treatment is to be performed may be included in the input data. Such data may include, but is not limited to, the following: ambulatory Surgery Center (ASC) contrasts hospitals, facility injury levels, joint replacement integrated care plan (CJR) or bundle candidate qualifications, MSA driven scores, community contrasted medicine, academic vs non-academic, post-operative network access (professional care facility [ SNF ], home care, etc..), medical staff availability, implant availability, and surgical equipment availability.

These facility inputs may be captured by, for example, but not limited to, surveys (paper/digital), surgical scheduling tools (e.g., applications, websites, electronic medical records [ EMRs ], etc.), hospital information databases (on the internet), and the like. Input data relating to the associated healthcare economy, including but not limited to the socioeconomic status of the patient, the expected reimbursement level that the patient will obtain, and if the treatment is patient-specific, may also be captured.

These healthcare economic inputs may be obtained through, for example, but not limited to, surveys (paper/digital), direct payer information, socioeconomic status databases (on the internet with zip codes), and the like. Finally, data from the simulation operation is captured. The analog inputs include implant size, position, and orientation. The anatomical modeling software program may be custom made or commercially available (e.g.,

AnyBody or OpenSIM). It should be noted that the above data input may not be available for each patient, and the treatment plan will be generated using the available data.

Prior to surgery, the patient data 310, 315 and medical personnel data 325 may be captured and stored in a cloud-based or online database (e.g., the surgical data server 180 shown in fig. 2C). The information relating to the procedure is provided to the computing system via wireless data transmission or manually through the use of a portable media storage device. The computing system is configured to generate a case plan for the CASS 100. Case plan generation will be described below. It should be noted that the system has access to historical data from previous patients receiving treatment, including implant size, placement, and orientation, generated by a computer-assisted, patient-specific knee joint instrumentation (PSKI) selection system, or automatically by the CASS 100 itself. To accomplish this, the surgical sales representative or case engineer uses an online portal to upload case log data to the history database. In some embodiments, the data transfer to the online database is wireless and automatic.

Historical data sets from online databases are used as inputs to machine learning models, such as Recurrent Neural Networks (RNNs) or other forms of artificial neural networks. As is generally understood in the art, an artificial neural network functions similarly to a biological neural network and is composed of a series of nodes and connections. The machine learning model is trained to predict one or more values based on input data. For the subsequent sections, it is assumed that the machine learning model is trained to generate the prediction equations. These prediction equations may be optimized to determine the optimal size, position, and orientation of the implant to achieve the best results or satisfaction.

Once the procedure is complete, all patient data and available outcome data, including implant size, position and orientation as determined by the CASS 100, are collected and stored in a historical database. Any subsequent calculation of the target equation via the RNN will include data from previous patients in this manner, allowing for continued improvement of the system.

In addition to or as an alternative to determining implant location, in some embodiments, predictive equations and associated optimizations may be used to generate an ablation plane for the PSKI system. When used with a PSKI system, predictive equation calculation and optimization is done prior to surgery. The patient anatomy is estimated using medical image data (x-ray, CT, MRI). Global optimization of the prediction equations may provide the desired size and location of the implant components. The boolean intersection of the implant component and the patient's anatomy is defined as the ablation volume. The PSKI may be generated to remove the optimized ablation envelope. In this embodiment, the surgeon is unable to change the surgical plan during the surgery.

The surgeon may choose to change the surgical case plan at any time before or during the surgery. If the surgeon chooses to deviate from the surgical case plan, changing the size, position, and/or orientation of the component is locked out and the global optimization is refreshed based on the new size, position, and/or orientation of the component (using the techniques previously described) to find other components and new ideal locations to perform the required corresponding resections to achieve the new optimized size, position, and/or orientation of the component. For example, if the surgeon determines that intraoperatively updating or modifying the size, position and/or orientation of the femoral implant in a TKA is required, the femoral implant position is locked relative to the anatomy, and the new optimal position of the tibia will be calculated (by global optimization) taking into account the surgeon's changes to the femoral implant size, position and/or orientation. Furthermore, if the surgical system used to implement the case plan is robotically-assisted (e.g., with)

Or MAKO Rio), bone removal and bone morphology during surgery can be monitored in real time. If the resection made during the procedure deviates from the surgical plan, the processor may optimize the subsequent placement of the additional components in view of the actual resection that has been made.

Fig. 4A illustrates how the surgical patient care system 320 may be adapted to perform a case plan matching service. In this example, data relating to the current patient 310 is captured and compared to all or part of a historical database of patient data and related results 315. For example, the surgeon may choose to compare the current patient's plan to a subset of the historical database. The data in the historical database may be filtered to include, for example, only data sets with favorable results, data sets corresponding to historical procedures for patients with profiles that are the same as or similar to the current patient profile, data sets corresponding to a particular surgeon, data sets corresponding to particular aspects of a surgical plan (e.g., procedures that retain only a particular ligament), or any other criteria selected by the surgeon or medical personnel. For example, if the current patient data matches or correlates with data of a previous patient experiencing good results, the case plan from the previous patient may be accessed and modified or used for the current patient. The predictive equations may be used in conjunction with an intra-operative algorithm that identifies or determines actions associated with a case plan. Based on relevant and/or preselected information from the historical database, the intraoperative algorithm determines a series of recommended actions to be performed by the surgeon. Each execution of the algorithm produces the next action in the case plan. If the surgeon performs the action, the result is evaluated. The results of the actions performed by the surgeon are used to refine and update the input to the intra-operative algorithm used to generate the next step in the case plan. Once the case plan has been fully executed, all data associated with the case plan, including any deviations from recommended actions performed by the surgeon, is stored in the historical data database. In some embodiments, the system utilizes preoperative, intraoperative, or postoperative modules in a segmented fashion as opposed to an entire continuous care. In other words, the caregiver may specify any permutation or combination of therapy modules, including the use of a single module. These concepts are illustrated in fig. 4B and may be applied to any type of procedure that utilizes the CASS 100.

Operation process display

As described above with respect to fig. 1-2C, the various components of the CASS 100 generate detailed data records during surgery. The CASS 100 may track and record various actions and activities of the surgeon during each step of the procedure and compare the actual activities to pre-or intra-operative surgical plans. In some embodiments, software tools may be used to process these data into a format that the procedure can effectively "playback". For example, in one embodiment, one or more GUIs may be used to depict all of the information presented on the intra-operative display 125. This may be supplemented with graphics and images depicting data acquired by different tools. For example, a GUI providing a visual depiction of the knee during tissue resection may provide measured torque and displacement of the resection device adjacent to the visual depiction to better provide an understanding of any deviation from the planned resection area that occurred. The ability to view surgical plan playback or switch between actual surgery and different aspects of the surgical plan may provide benefits to the surgeon and/or surgical personnel, allowing such personnel to identify any deficient or challenging aspects of the surgery so that modifications may be made in future surgeries. Similarly, in an academic environment, the aforementioned GUI may be used as an instructional tool for training future surgeons and/or surgical personnel. In addition, because the data set effectively records many aspects of the surgeon's activity, it may also be used as evidence of correct or incorrect performance of a particular surgical procedure for other reasons (e.g., legal or compliance reasons).

Over time, as more and more surgical data is collected, a rich database may be obtained that describes the surgical procedures that different surgeons perform for different types of anatomical structures (knee, shoulder, hip, etc.) for different patients. In addition, aspects such as implant type and size, patient demographics, and the like may be further used to enhance the overall data set. Once the data set has been established, it can be used to train a machine learning model (e.g., RNN) to predict how the procedure will proceed based on the current state of the CASS 100.

The training of the machine learning model may be performed as follows. The overall state of the CASS 100 may be sampled over a number of time periods for the duration of the procedure. The machine learning model may then be trained to translate the current state at the first time period to a future state at a different time period. By analyzing the entire state of the CASS 100, rather than individual data items, any causal relationship of interactions between different components of the CASS 100 can be captured. In some embodiments, multiple machine learning models may be used instead of a single model. In some embodiments, the machine learning model may be trained not only with the state of the CASS 100, but also with patient data (e.g., captured from the EMR) and the identification of the members of the surgical personnel. This allows the model to predict with greater specificity. Furthermore, it allows the surgeon to selectively predict, if desired, based solely on his own surgical experience.

In some embodiments, the predictions or recommendations made by the aforementioned machine learning model may be integrated directly into the surgical workflow. For example, in some embodiments, the surgical computer 150 may execute a machine learning model in the background to predict or recommend an impending action or surgical condition. Thus, multiple states may be predicted or recommended for each period. For example, surgical computer 150 may predict or recommend the state for the next 5 minutes in 30 second increments. With this information, the surgeon can utilize a "course display" view of the procedure that allows visualization of future states. For example, fig. 4C depicts a series of images that may be displayed to a surgeon that depicts an implant placement interface. The surgeon may cycle through these images, for example, by entering a particular time into the display 125 of the CASS 100 or instructing the system to advance or retract the display at particular time increments using tactile, verbal, or other instructions. In one embodiment, the procedure display may be presented in the AR HMD in the upper portion of the surgeon's field of view. In some embodiments, the process display may be updated in real-time. For example, as the surgeon moves the ablation tool around the planned ablation region, the procedure display may be updated so that the surgeon can see how his actions are affecting other aspects of the procedure.

In some embodiments, rather than simply using the current state of the CASS 100 as an input to the machine learning model, the inputs to the model may include a projected future state. For example, the surgeon may indicate that he is planning a particular bone resection of the knee joint. The instructions may be manually entered into surgical computer 150, or the surgeon may provide the instructions verbally. The surgical computer 150 can then generate a membrane strip showing the predicted effect of the cut on the surgery. This membrane strip may describe, at certain time increments, how the surgery will be affected, including, for example, changes in the patient's anatomy, changes in implant position and orientation, and changes with respect to surgery and instruments if the envisaged course of action is to be performed. A surgeon or medical personnel may invoke or request this type of membrane strip at any point in the procedure to preview how the envisaged course of action will affect the surgical plan if the envisaged action is to be taken.

It should also be noted that with a fully trained machine learning model and robotic CASS, various aspects of the procedure may be automated such that the surgeon need only participate minimally, for example, by providing only consent to various steps of the procedure. For example, over time, robotic control using arms or other devices may be increasingly integrated into surgical workflows, where surgeons are increasingly engaged in manual interaction less and less than robotic operations. In this case, the machine learning model may learn which robot commands are needed to reach certain states of implementing the CASS plan. Finally, the machine learning model may be used to generate a membrane strip or similar view or display that predicts and may preview the entire procedure from an initial state. For example, an initial state may be defined that includes patient information, surgical plan, implant characteristics, and surgeon preferences. Based on this information, the surgeon can preview the entire procedure to confirm that the CASS recommended plan meets the surgeon's expectations and/or requirements. Further, since the output of the machine learning model is the state of the CASS 100 itself, commands may be derived to control components of the CASS to achieve each predicted state. In extreme cases, the entire procedure can therefore be automated based on the initial state information only.

High resolution acquisition of critical areas during hip surgery using point probes

The use of a spot probe is described in U.S. patent application No. 14/955,742 entitled "Systems and Methods for Planning and Performing Image Free Implant Revision Surgery," the entire contents of which are incorporated herein by reference. In short, optically tracked point probes can be used to delineate the actual surface of the target bone requiring a new implant. Mapping is performed after removal of the defective or worn implant, and after removal of any diseased or unwanted bone. Multiple points are collected on the bone surface by brushing or scraping all of the remaining bone with the tip of a point probe. This is known as drawing or "painting" the bone. The collection points are used to create a three-dimensional model or surface map of the bone surface in a computerized planning system. The created 3D model of the remaining bone is then used as a basis for planning the surgery and the necessary implant size. An alternative technique for using X-rays to determine 3D models is described in united states provisional patent application No. 62/658,988 entitled "Three Dimensional Guide with Selective Bone Matching" filed on 2018, month 4, and day 17, which is incorporated herein by reference in its entirety.

For hip applications, point probe painting (point probe painting) can be used to obtain high resolution data of critical areas, such as the acetabular rim and acetabular fossa. This may allow the surgeon to obtain a detailed view before reaming begins. For example, in one embodiment, a point probe may be used to identify the floor (socket) of the acetabulum. As is well known in the art, in hip surgery, it is important to ensure that the floor of the acetabulum is not damaged during reaming in order to avoid damage to the inner sidewall. If the medial wall is inadvertently damaged, the procedure will require an additional step of bone grafting. In this regard, information from the point probe may be used to provide guidance to the acetabular reamer during the surgical procedure. For example, the acetabular reamer may be configured to provide tactile feedback to the surgeon when the surgeon reaches the undersurface or otherwise deviates from the surgical plan. Alternatively, the CASS 100 may automatically stop the reamer when the bottom surface is reached or when the reamer is within a threshold distance.

As an additional safeguard, the thickness of the area between the acetabulum and the medial wall can be estimated. For example, once the acetabular rim and acetabular fossa have been stained and registered to the pre-operative 3D model, the thickness can be readily estimated by comparing the location of the acetabular surface to the location of the medial wall. With this knowledge, the CASS 100 can provide an alarm or other response upon reaming if any surgical activity is predicted to protrude through the acetabular wall.

The point probe may also be used to acquire high resolution data for orienting the 3D model to a common reference point of the patient. For example, for pelvic plane landmarks such as ASIS and pubic symphysis, the surgeon may use a point probe to stain the bone to represent the true pelvic plane. Given a more complete view of these landmarks, the registration software has more information to orient the 3D model.

The point probe may also be used to acquire high resolution data describing the proximal femoral reference point, which may be used to improve the accuracy of implant placement. For example, the relationship between the tip of the Greater Trochanter (GT) and the center of the femoral head is often used as a reference point to align femoral components during hip arthroplasty. The alignment height depends on the proper position of the GT; thus, in some embodiments, a point probe is used to stain the GT to provide a high resolution view of the region. Similarly, in some embodiments, it may be useful to have a high resolution view of the smaller rotor (LT). For example, during hip arthroplasty, the Dorr classification facilitates selection of a stem that will maximize the ability to achieve a press fit during surgery to prevent post-operative micromotion of the femoral component and ensure optimal bone ingrowth. As understood in the art, the Dorr classification measures the ratio between the tube width at LT and the tube width 10cm below LT. The accuracy of the classification is highly dependent on the correct position of the relevant anatomical structure. Therefore, it may be advantageous to dye LT to provide a high resolution view of this region.

In some embodiments, a point probe is used to dye the femoral neck to provide high resolution data that allows the surgeon to better understand where the neck cut is made. The navigation system may then guide the surgeon as the surgeon performs the neck cut. For example, as understood in the art, the femoral neck angle is measured by placing one line along the center of the femoral axis and a second line along the center of the femoral neck. Thus, a high resolution view of the femoral neck (and possibly also the femoral axis) will provide a more accurate calculation of the femoral neck angle.

The high resolution femoral head neck data can also be used to navigate a resurfacing procedure where software/hardware assists the surgeon in preparing the proximal femur and placing femoral components. As is generally understood in the art, during hip resurfacing, the femoral head and neck are not removed; instead, the head is trimmed and covered on top with a smooth metal cover. In this case, it would be advantageous for the surgeon to dye the femoral head and cap so that an accurate assessment of their respective geometries can be understood and used to guide the trimming and placement of the femoral component.

Registration of preoperative data to patient anatomy using point probe

As described above, in some embodiments, a 3D model is developed during the preoperative phase based on 2D or 3D images of the anatomical region of interest. In such embodiments, registration between the 3D model and the surgical site is performed prior to the surgical procedure. The registered 3D models may be used to intra-operatively track and measure the patient's anatomy and surgical tools.

During a surgical procedure, landmarks are acquired to facilitate registration of the pre-operative 3D model to the patient's anatomy. For knee surgery, these points may include femoral head center, distal femoral axis point, medial and lateral epicondyles, medial and lateral ankles, proximal tibial mechanical axis point, and tibial a/P direction. For hip surgery, these points may include the Anterior Superior Iliac Spine (ASIS), pubic symphysis, points along the acetabular rim and within the hemisphere, the Greater Trochanter (GT) and the Lesser Trochanter (LT).

In revision surgery, the surgeon may stain certain areas containing anatomical defects to allow for better visualization and navigation of implant insertion. These defects may be identified based on analysis of the preoperative images. For example, in one embodiment, each preoperative image is compared to a library of images showing "healthy" anatomy (i.e., defect free). Any significant deviation between the patient's image and the healthy image may be flagged as a potential defect. The surgeon may then be alerted of a possible defect via a visual alarm on the display 125 of the CASS 100 during the procedure. The surgeon may then stain the area to provide further details about the potential defect to the surgical computer 150.

In some embodiments, the surgeon may register the incision within the bony anatomy using a non-contact approach. For example, in one embodiment, laser scanning is used for registration. Laser stripes are projected over an anatomical region of interest and changes in the height of the region are detected as changes in the lines. Other non-contact optical methods, such as white light inference or ultrasound, may alternatively be used for surface height measurement or registration of the anatomy. For example, ultrasound techniques may be beneficial when there is soft tissue between the registration point and the bone being registered (e.g., ASIS, pubic symphysis in hip surgery), thereby providing a more accurate definition of the anatomical plane.

The present disclosure describes force indicating devices and methods of using force indicating devices. By using the device intra-operatively, for example during TKA performance, the amount of force applied to the knee joint during joint laxity assessment can be quantified. Further, a surgeon or other medical personnel performing joint slack assessment during surgery may be able to apply a consistent amount of force to the joint in one or more directions of motion.

Fig. 5A depicts an illustrative device according to an embodiment. As shown in fig. 5A, device 500 can include a tissue retractor 505, a handle 510, and one or more force indicators 530 (in fig. 5B). The tissue retractor may include an insertion end 515 and a base end 520. In an embodiment, tissue retractor 505 may be curved such that insertion end 515 and base end 520 may be positioned at an angle relative to each other. In an embodiment, the angle may be an acute angle. In an embodiment, the angle may be an obtuse angle. In an embodiment, the angle may be a right angle. In an embodiment, tissue retractor 505 may be straight such that insertion end 515 and base end 520 may be aligned along the same spatial plane. In embodiments, the insertion end 515 of the tissue retractor 505 may be configured to be inserted between a femoral condyle and a corresponding tibial condyle of the knee. In alternative embodiments, the insertion end 515 of the tissue retractor 505 may be configured to be inserted between two condyles of a femur and corresponding two condyles of a tibia of a knee.

Fig. 5B depicts an interior view of the illustrative device depicted in fig. 5A. As shown in fig. 5B, in embodiments, one or more force indicators 530 can be positioned adjacent to base end 520 of tissue retractor 505. In an embodiment, the one or more force indicators 530 may be one or more strain gauges. In an embodiment, one or more strain gauges may have a wheatstone bridge configuration. In some embodiments, one or more pressure sensors or force indicators 530 may be located on insertion end 515, pivot feature 525, and/or base end 520. In some embodiments, the device 500 may include an array of sensors or force indicators 530 to measure force values. In such embodiments, the force values measured by sensor 530 may be averaged to provide a more accurate reading. Other sensors and/or other locations for such sensors will be apparent to one of ordinary skill in the relevant art.

In embodiments, the tissue retractor 505 can further comprise a pivot feature 525 configured to concentrate stress at an existing bend in the tissue retractor 505. In embodiments, the tissue retractor 505 can further comprise a pivot feature 525 configured to concentrate stress at a predetermined location on the tissue retractor 505. The base end 520 of tissue retractor 505 can be connected to a handle 510. In an embodiment, handle 510 can enclose a portion of base end 520 of tissue retractor 505. In an embodiment, the handle 510 may enclose a portion of the base end 520 where one or more force indicators 530 are located. In an embodiment, the apparatus 500 may include a converter (not shown) configured to convert the analog force measurement into digital data. In an embodiment, the converter may include a signal amplifier (not shown).

As shown in fig. 5C, 5D, and 5E, in additional or alternative embodiments, the apparatus 500 may have wireless communication capabilities. Accordingly, as shown in fig. 5C, instead of display 535, device 500 may be marked 540 to refer toA wireless connection is shown. In another embodiment, the device 500 may be associated with one or more surgical navigation systems, for example

The surgical navigation system is in wireless communication. Direct transmission of the measured tension helps to reduce or eliminate potential user error and does not require subjective ligament tensioning. In some embodiments, and as shown, device 500 can still include one or more force indicators 530, which can be positioned adjacent to base end 520 of tissue retractor 505.

Thus, in some embodiments, the handle 510 of the device 500 may house various components 545, such as a Radio Frequency (RF) module, an on-board signal amplifier, a power supply, a microcontroller unit (MCU), an integrated circuit, and the like. Thus, as discussed further herein, the tension measured by the device 500, which may include, but is not limited to, a maximum force, a minimum force, an average force, a force over a period of time, a force angle, a force vector, etc., may be transmitted directly to the CASS to improve the surgical plan or the surgical procedure performed.

As shown in fig. 5A, 5B, the apparatus 500 may include a display 535. In an embodiment, the display 535 may be in electronic communication with one or more force indicators 530. Display 535 may display information related to, for example, the force applied to device 500. In an embodiment, the display 535 may be a digital display. In an embodiment, the force indicator 530 may be a digital force indicator having a display 535. In some embodiments, the digital force indicator 530 may be configured to record one or more measurements and provide at least one of such measurements to the display 535. For example, the digital force indicator 530 may be configured to record one or more of a minimum force measurement and a maximum force measurement. The minimum force measurement may indicate the magnitude of the minimum force applied to the device 500 when testing joint laxity. Similarly, the maximum force measurement may indicate the magnitude of the maximum force applied to the device 500 when testing joint laxity. It is within the scope of the present disclosure that additional and/or alternative measurements may be recorded by the digital force indicator 530. In any of these embodiments, the force indicator 530 may be configured to electronically record the magnitude of the force applied to the portion of the body and transmit the record of the magnitude of the force to the computer.

In an embodiment, the apparatus 500 may further include a power source (not shown). In an embodiment, the power source may be a wire. In alternative embodiments, the power source may be a wireless power source, including a stationary battery, a removable battery, a fluctuating magnetic field, a photovoltaic array, or any combination thereof.

In an embodiment, the device 500 may also include one or more location tracking devices (not shown). In an embodiment, the one or more position tracking devices may be an optical tracking array. In one embodiment, the one or more position tracking devices may be fixedly attached to the device 500. In an embodiment, the one or more position tracking devices may be removably attached to the device 500. In an embodiment, the device 500 may include one or more attachment features configured to receive the one or more position tracking devices in a fixed manner. In an embodiment, the device 500 may include one or more attachment features configured to removably receive one or more position tracking devices.

In some embodiments, one or more position tracking devices may be configured to record one or more position data points indicative of one or more of the position, orientation, and motion of device 500 and provide at least one of these data points to a computer. In an embodiment, one or more position tracking devices may be configured to record one or more position data points that may indicate linear motion of the device or one or more components thereof as the device 500 is moved. In an embodiment, one or more position tracking devices may be configured to record one or more position data points as the device 500 is moved in a manner that may indicate rotational motion of the device or one or more components thereof. In an embodiment, one or more position tracking devices may be configured to record one or more position data points that may indicate a twist of the device or one or more components thereof as the device 500 is moved.

In an embodiment, one or more position tracking devices may be configured to record one or more position data points that may indicate bending of the device or one or more components thereof as the device 500 is moved. In some embodiments, the one or more tracking devices may include displacement sensors, such as reflective sensors, LED position sensors, piezoelectric effect sensors, hall effect sensors, inductive sensors, micro-electromechanical system (MEMS) sensors, piezoresistive sensors, load sensors, ultrasonic resonators combined with compressible propagating structures, capacitive sensors, temperature sensors, and the like.

Fig. 5F depicts an illustrative device according to an alternative embodiment. As shown in fig. 5F, device 500F can include tissue retractor 505F, handle 510F, and one or more force indicators 530F. The tissue retractor can include an insertion end 515F and a base end 520F. In embodiments, device 500F can have one or more force indicators 530F located on insertion end 515F of tissue retractor 505F. In an embodiment, one or more force indicators 530F may include a pressure sensor, such as a piezoelectric effect sensor. Other pressure sensors will be apparent to those of ordinary skill in the relevant art. In an embodiment, the device 500F may have a display 535F. In embodiments, insertion end 515F of tissue retractor 505F may comprise a paddle sized and shaped for insertion between a condyle of a femur and a corresponding condyle of a tibia of a knee. In alternative embodiments, insertion end 515F of tissue retractor 505F may comprise a plurality of paddles sized and shaped for insertion between a condyle of a femur and a corresponding condyle of a tibia of a knee. In some embodiments, the device 500F may include an array of force indicators 530F. In such embodiments, the force values measured by the force indicators may be averaged to provide a more accurate reading.

6A, 6B, 6C, and 6D depict illustrative devices according to another alternative embodiment. As shown in fig. 6A, 6B, 6C, and 6D, device 600 can include a tissue retractor 605 having: a first prong 615 having an insertion end 620 and a base end 625; a second prong 630 having an insertion end 635 and a base end 640; at least two handles 645, 650; and one or more force indicators disposed about the rotational joint 660. The rotational spring is wound around the rotational joint 660. In an embodiment, the rotation spring may be a torsion spring. The first prong 615 and the second prong 630 of the tissue retractor 605, the at least two handles 645, 650, and the rotational spring are configured such that the first prong 615 and the second prong 630 of the tissue retractor 605 can pivot about the rotational joint 660 when a force is applied to the at least two handles 645, 650.

In an embodiment, the one or more force indicators are configured to trigger when the at least two handles 645, 650 reach a point of displacement relative to each other that reaches a predetermined torque. In embodiments, the one or more force indicators are one or more electrical or magnetic sensors, such as piezoelectric effect sensors, hall effect sensors, inductive sensors, or any combination thereof. In some embodiments, the one or more force indicators comprise one or more of the following sensors: micro-electro-mechanical system (MEMS) sensors, piezoresistive sensors, load sensors, ultrasonic resonators combined with compressible propagating structures, capacitive sensors, and/or temperature sensors. Other pressure sensors will be apparent to those of ordinary skill in the relevant art. In some embodiments, the device 600 may include an array of force indicators. In such embodiments, the force values measured by the force indicator may be averaged to provide a more accurate reading of the applied force.

As shown in fig. 6A, 6B, and 6C, in an embodiment, the first prong 615 and the second prong 630 of the tissue retractor 605 are separated in the open position when the rotational spring is in its intermediate position and mate together in the closed position when a force is applied to the at least two handles 645, 650. In an alternative embodiment, the first prong 615 and the second prong 630 of the tissue retractor 605 mate together when the rotational spring is in the intermediate position, separating to the open position upon application of a force to the at least two handles 645, 650. In an embodiment, the first prong 615 and the second prong 630 of the tissue retractor 605 are sized and shaped to rest against each other when in the closed position.

In embodiments, one or more of the insertion ends 620, 635 of the first prong 615 and the second prong 630 of the tissue retractor 605 may include a paddle sized and shaped for insertion between a femoral condyle and a corresponding tibial condyle in the knee.

In alternative embodiments, one or more of the insertion ends 620, 635 of the first prongs 615 and the second prongs 630 of the tissue retractor 605 may include a plurality of paddles sized and shaped for insertion between the femoral condyle and a corresponding tibial condyle in the knee. In one embodiment, as shown in fig. 6A, 6B, the first prong 615 may further comprise a cavity 670 having a size and shape corresponding to the size and shape of at least a portion of the second prong 630, such that a portion of the second prong is located within the first prong when the first and second prongs are in the closed position.

In an embodiment, one or more of the insertion end 620 of the first tine 615 and the insertion end 635 of the second tine 630 of the tissue retractor 605 includes a joint-facing surface configured to engage an articular surface of a joint when the insertion end of the first tine and the insertion end of the second tine are inserted in the joint. In an embodiment, one or more of the insertion end 620, joint-facing surface of the first prong 615 and the insertion end 635 of the second prong 630 further comprise one or more engagement features 675 configured to engage an articular surface of a joint. In one embodiment, as illustrated in fig. 6C, 6D, only the joint-facing surface of the insertion end 620 of the first prong 615 may include one or more engagement features 675.

Fig. 7A and 7B depict the illustrative device of fig. 5A and 5B inserted into a knee joint, according to an embodiment. In an embodiment, the force applied to the handle 510 of the device 500 distal of the insertion point can further bend the existing bend in the tissue retractor 505. In an embodiment, the force applied to the handle 510 of the device 500 distal to the insertion point may be focused at a predetermined location by the pivoting feature 525. As shown in fig. 7A, 7B, the insertion end 515 of the tissue retractor 505 may be sized and shaped for insertion between one condyle of a femur and a corresponding condyle of a tibia of a knee. In an embodiment, insertion end 515 of tissue retractor 505 of device 500 can be inserted between the medial condyle of femur 705 and the medial condyle of tibia 710 of knee 700 of a patient. In alternative embodiments, insertion end 515 of tissue retractor 50a5 may include a plurality of paddles sized and shaped to be inserted between the two condyles of the femur and the corresponding two condyles of the tibia of the knee.

Referring now to fig. 8A-8C, there may be additional embodiments where the original tissue retractor (fig. 5, 505) is removable and replaceable. As shown in fig. 8A, device 500 can have alternative tissue retractors 505A, 505B, 505C. In some embodiments, the device 500 can have a protrusion 555A that is complementary to one or more recesses 560 in the new tissue retractor 505A. It is to be appreciated that the coupling mechanism between device 500 and replacement tissue retractor 505A can rely on any means capable of securing the replacement tissue retractor in place (e.g., mechanical coupling, magnetic coupling, electromagnetic coupling, etc.). In additional or alternative embodiments, the projections 555A, 555B, 555C and recesses 560A, 560B, 560C may have one of a variety of complementary shapes, for example, as shown in fig. 8B, wherein the projections and recesses have rounded corners. Further, it should be understood that various other shapes may be utilized, such as octagons, stars, etc.

In another embodiment, the tissue retractors 505A, 505B, 505C may have various shapes, sizes, orientations, etc. based on the needs of the tensioning device. For example, the tissue retractor can be used in connection with, but not limited to, knee surgery, hip surgery, spine surgery, and the like, for any type of tensioning requirement.

Fig. 9 depicts a block diagram of an illustrative system for measuring forces applied to a joint during a surgical procedure, according to an embodiment. As shown in fig. 9, the system 900 may include a computer 905, an apparatus 910, and a patient tracking system 915. The device 910 may include one or more location tracking devices 920. The one or more position tracking devices 920 may be an optical tracking array. The device 910 may also include one or more force indicators 925. In some examples, system 900 may include more or fewer components. For example, in some embodiments, the system 900 may not include the patient tracking system 915 or the location tracking device 920.

In an embodiment, the computer 905 is in electronic communication with the apparatus 910. In an embodiment, the computer 905 is a robotic surgical system. In an embodiment, the computer 905 is a surgical system. In an embodiment, the computer 905 is in electronic communication with one or more position tracking device apparatuses 920. In an embodiment, computer 905 is in electronic communication with one or more force indicators 925. In an embodiment, the electronic communication may be wired. In an embodiment, the electronic communication may be performed using a wireless transmission system. The wireless transmission system may receive information from one or more position tracking devices 920 and convert the information into digital information, which may be wirelessly transmitted to the computer 905. The wireless transmission system may also receive information from one or more force indicators 925 and convert the information into digital information, which may be wirelessly transmitted to computer 905.

In an embodiment, the robotic surgical system 900 is additionally in electronic communication with the patient tracking system 915. In an embodiment, the electronic communication may be wired. In an embodiment, the electronic communication may be performed using a wireless transmission system. The wireless transmission system may receive information from the patient tracking system 915 and convert the information into digital information, which may be wirelessly transmitted to the computer 905. In an embodiment, the patient tracking system 915 is configured to attach to one or more portions of the patient's anatomy into which the device 910 is inserted to improve the accuracy of measurements obtained using the device.

In an embodiment, the patient tracking system 915 includes one or more trackers 930. In an embodiment, one or more trackers 930 may be an optical tracking array. In an embodiment, the one or more trackers 930 are configured to record one or more location data points indicative of one or more of a position, orientation, and motion of the device, and provide at least one of these data points to the computer 905. One or more trackers 930 may be attached to one or more of the patient's tibia and femur. In an embodiment, one or more trackers 930 may be attached to each of the patient's tibia and femur, and may be configured to record one or more location data points that may indicate the relative orientation of the tibia and femur when the device 910 is inserted and moved between the patient's tibia and femur, for example, when a force is applied to the handle of the device. In an embodiment, the relative orientation of the tibia and the femur is the position of the tibia and the femur. In an embodiment, the relative orientation of the tibia and the femur is the distance between the tibia and the femur. In an embodiment, the relative orientation of the tibia and the femur is an angle of the tibia and the femur relative to one or more of a distal-proximal axis, an anterior-posterior axis, and a medial-lateral axis. In an embodiment, the relative orientation of the tibia and the femur is the flexion angle of the tibia and the femur.

In an embodiment, computer 905 is configured to receive data from one or more of device 910 or components thereof, one or more position tracking devices 920, and one or more force indicators 925. In an embodiment, the computer 905 is configured to receive data from the patient tracking system 915.

Fig. 10A depicts a flowchart 1000A of an illustrative method of measuring a force applied to a joint during a surgical procedure, according to an embodiment. As shown in fig. 10A, a device may be inserted 1005A into a portion of a joint, a force may be applied 1010A to the device, and the force applied by 1015A may be measured. In some embodiments, the joint may be a knee. However, it is within the scope of the present disclosure that the device may be inserted 1005A into other joints, such as shoulders, elbows, ankles, hips, and the like. A device to be inserted can include a tissue retractor having an insertion end and a base end, a handle, and one or more force indicators, such as the devices also described herein.

In an embodiment, the force may be applied 1010A to a handle of the device distal to the joint. As also described herein, applying force in this manner can result in displacement of the insertion end of the tissue retractor relative to the base end. In an embodiment, the force applied by 1015A may be measured by one or more force indicators. In an embodiment, the one or more force indicators may be configured to electronically record the amount of force applied to the joint portion. In an embodiment, the one or more force indicators may be configured to electronically record the magnitude of the force applied to the body portion and transmit the record of the magnitude of the force to a computer comprising the robotic surgical system or the surgical system.

In an alternative embodiment, as also described herein, applying force 1010A to the handle of the device can displace the insertion end relative to the articulating portion into which it is inserted, thereby creating pressure against the insertion end of the device. The one or more force indicators may be configured to record the amount of pressure applied to the insertion end of the device. In an embodiment, the one or more force indicators may be configured to electronically record 1015A magnitude of the force applied to the body portion and transmit the record of the magnitude of the force to a computer comprising the robotic surgical system or the surgical system.

In an alternative embodiment, the device to be inserted may further comprise a tissue retractor having: a first prong having an insertion end and a base end; a second prong having an insertion end and a base end; at least two handles; and one or more force indicators disposed about the rotational joint. The rotary spring is wound around the rotary joint. Applying the force 1010A to the handle of the device can generate a torque that applies a force against an articulating portion of the tissue retractor into which the insertion end is inserted. When the handle reaches a point of displacement that reaches a predetermined torque, the one or more force indicators may be configured to electronically record the magnitude of the force applied to the body portion and transmit the record of the magnitude of the force to a computer comprising the robotic or surgical system.

In another embodiment, the device may also include one or more position tracking devices configured to record one or more position, orientation, and motion data points that may indicate motion of the device or one or more components thereof (e.g., the device described further herein) while the device is being moved. One or more position, orientation, and motion data points may be received by a computer comprising a robotic surgical system or surgical system and used to account for the motion of the device when applying 1010A force in order to facilitate more accurate measurement of the applied force.

In another embodiment, the patient tracking system may be attached to the joint portion prior to applying force 1010A. The patient tracking system may include one or more position trackers configured to record one or more position, orientation, and motion data points indicative of a portion of a joint (e.g., a device described further herein) while moving the device. One or more position, orientation, and motion data points may be received by a computer comprising a robotic surgical system or surgical system and used to account for the motion of the joint portion when 1010A force is applied in order to facilitate more accurate measurement of the applied force.

Fig. 10B depicts a flowchart 1000B of an illustrative method of measuring intra-articular forces in a joint during a surgical procedure, according to an embodiment. As shown in fig. 10B, the device may be inserted 1005B into a portion of a joint. In some embodiments, the joint may be a knee. However, it is within the scope of the present disclosure that the device may be inserted into other joints, such as shoulders, elbows, ankles, hips, and the like. A device to be inserted can include a tissue retractor having an insertion end and a base end, a handle, and one or more force indicators, such as the devices also described herein.

In an embodiment, the joint may bend 1010B as the device moves so that the position and orientation of the device relative to at least a portion of the joint may be maintained. Bending the joint in this manner, while maintaining the position and orientation of the device relative to the joint, may cause the insertion end of the tissue retractor to shift relative to the base end, as also described herein. In an embodiment, the force applied by 1015B may be measured by one or more force indicators, which may be configured to electronically record the magnitude of the force resulting from the joint bending. In an embodiment, the one or more force indicators may be configured to electronically record the magnitude of the force applied to the body portion and transmit the record of the magnitude of the force to a computer comprising the robotic surgical system or the surgical system.

In an alternative embodiment, the joint may bend 1010B such that the articular surface of the joint applies pressure to the insertion end of the device. As also described herein, the one or more force indicators may be configured to record the amount of pressure applied to the insertion end of the device. In an embodiment, the one or more force indicators may be configured to electronically record the magnitude of the force applied 1015B to the body portion and transmit the record of the magnitude of the force to a computer comprising the robotic surgical system or the surgical system.

In an alternative embodiment, the device to be inserted may further comprise a tissue retractor having: a first prong having an insertion end and a base end; a second prong having an insertion end and a base end; at least two handles; and one or more force indicators disposed about the rotational joint. The rotary spring is wound around the rotary joint. Bending the joint 1010B may cause the articulating surfaces of the joint to apply pressure to the insertion ends of the first prong and the second prong of the device, thereby causing displacement of the handles relative to each other. When the handle reaches a point of displacement that reaches a predetermined torque, the one or more force indicators may be configured to electronically record the magnitude of the force applied to the body portion and transmit the record of the magnitude of the force to a computer comprising the robotic or surgical system.

In another embodiment, the device may also include one or more position tracking devices configured to record one or more position, orientation, and motion data points that may indicate motion of the device or one or more components thereof (e.g., the device described further herein) while the device is being moved. One or more position, orientation, and motion data points may be received by a computer comprising a robotic surgical system or surgical system and used to account for the motion of the device when applying 1010B force in order to facilitate more accurate measurement of the applied force.

In another embodiment, the patient tracking system may be attached to the joint portion prior to applying 1010B force. The patient tracking system may include one or more position trackers configured to record one or more position, orientation, and motion data points indicative of a portion of a joint (e.g., a device described further herein) while moving the device. One or more position, orientation, and motion data points may be received by a computer comprising a robotic surgical system or surgical system and used to account for the motion of the joint portion when applying 1010B force in order to facilitate more accurate measurement of the applied force.

Fig. 11 depicts an illustrative device according to an embodiment. As shown in fig. 11, device 1100 can include a tissue retractor 1105 and a force indicator 1110. Tissue retractor 1105 can be substantially z-shaped and can include a body 1115 and a tongue 1120 contained within the confines of the body. The tongue member 1120 may include a first long side 1125A, a second long side 1125B, a first short side 1125C, and a second short side 1125D. The tongue member 1120 is connected to the body 1115 only along the first short side 1125C. In other words, first long side 1125A, second long side 1125B, and second short side 1125D may not be directly attached to any other portion of body 1115.

The force indicator 1110 can be coupled to the body 1115. In an embodiment, the force indicator 1110 may be connected to the body 1115 at a location adjacent the second short side 1125D. In an embodiment, the force indicator 1110 may be an analog meter that includes at least one indicia corresponding to at least one force measurement. In such embodiments, tongue 1120 may be configured to act as a pointer to an analog meter when a force is applied to a portion of body 1115.

Fig. 12 depicts the device of fig. 11 inserted into a knee joint, according to an embodiment. As shown in fig. 12, the apparatus 1100 is insertable between a femur 1205 and a tibia 1210 of a knee 1200 of a patient. In an embodiment, a certain amount of force may be applied to a portion of the device 1100 distal to the insertion point, which may create a deflection angle between the body 1115 and the tongue 1120.

Referring back to fig. 11, tongue 1120 may be configured to be parallel to the portion of body 1115 surrounding the tongue when no force is applied to the body. In an embodiment, tongue 1120 may be configured to displace from the portion of body 1115 surrounding the tongue when a certain amount of force is applied to at least a portion of the body. In an embodiment, the angle of displacement between the body 1115 and the tongue 1120 may be proportional to the force applied to the body portion. For example, the angle of displacement between the body 1115 and the tongue 1120 may be directly proportional or linearly proportional to the force applied. Alternatively, the angle of displacement between the body 1115 and the tongue 1120 may be logarithmically proportional to the force applied. Other relationships between the angle of displacement and the applied force may also occur depending on the precise nature and configuration of the tongue 1120 and body 1115, as will be apparent to those of ordinary skill in the relevant art.

FIG. 14 depicts an illustrative device according to an alternative embodiment. As shown in fig. 14, device 1400 may include a tissue retractor 1405 and a force indicator 1410. The tissue retractor 1405 may be a Hohmann-type retractor and may include a body 1415 and a tongue 1420 contained within the confines of the body. The tongue component 1420 may comprise a first long side 1425A, a second long side 1425B, a first short side 1425C and a second short side 1425D. The tongue member 1420 is connected to the body 1415 only along the first short side 1425C. In other words, the first long side 1425A, the second long side 1425B, and the second short side 1425D may not be directly attached to any other portion of the body 1415.

The force indicator 1410 may be connected to a body 1415. In an embodiment, the force indicator 1410 may be connected to the body 1415 at a location adjacent to the second short side 1425D. In an embodiment, the force indicator 1410 may be an analog meter that includes at least one marker corresponding to at least one force measurement. In such embodiments, tongue 1420 may be configured to act as a pointer to an analog meter when a force is applied to a portion of body 1415.

In an embodiment, the tongue 1420 can be configured to be parallel to the body 1415 when no force is applied to the body. In an embodiment, the tongue 1420 may be configured to displace from the body 1415 when a certain amount of force is applied to at least a portion of the body. In an embodiment, the displacement angle between the body 1415 and tongue 1420 may be proportional to the force applied to the body portion. For example, the displacement angle between the body 1415 and tongue 1420 may be proportional to the force applied. Alternatively, the displacement angle between the body 1415 and tongue 1420 may be logarithmically proportional to the force applied. Other relationships between displacement angle and applied force may also occur depending on the precise nature and configuration of tongue 1420 and body 1415, as will be apparent to one of ordinary skill in the relevant art.

Fig. 15 depicts a flow diagram of an illustrative method of measuring a force applied to a joint during a surgical procedure, according to an embodiment. As shown in fig. 15, the device may be inserted 1505 into a portion of a joint. In some embodiments, the joint may be a knee. However, it is within the scope of the present disclosure that the device may be inserted 1505 into other joints, such as shoulders, elbows, ankles, hips, etc. The device to be inserted may include a tissue retractor having a body and a tongue component and a force indicator coupled to the body, such as the devices described further herein.

A force may be applied 1510 to a portion of the body. In an embodiment, a force may be applied 1510 to a body portion of the device distal to the joint. Applying a force in this manner may displace the tongue at an angle from the portion of the body surrounding the tongue. This displacement angle may be used to measure 1515 the amount of force applied to the body using the force indicator. For example, the angle at which the tongue is displaced from the body may indicate the amount of force as compared to the force indicator. Alternatively, the force indicator may be configured to electronically record the magnitude of the force applied to the body portion. In an embodiment, the force indicator may be configured to electronically record the magnitude of the force applied to the body portion and transmit the record of the magnitude of the force to the robotic surgical system.

The methods and systems disclosed herein are described with reference to LIFEMODELER KneeSIM Lab, provided by lifemodel, inc. However, one of ordinary skill in the art will recognize that the methods described herein may be performed using a variety of additional and/or alternative multi-body musculoskeletal analysis applications, including OpenSim, AnyBody (AnyBody Technology of Salem, MA) or Adams (MSC Software corp. of Newport Beach, CA).

FIG. 16 shows a block diagram of an illustrative data processing system 1600 in which aspects of the illustrative embodiments may be implemented. Data processing system 1600 is one example of a computer, such as a server or a client, in which computer usable code or instructions implementing the processes for illustrative embodiments of the present invention may be located. In some embodiments, data processing system 1600 may be a server computing device. For example, data processing system 1600 may be implemented in a server or another similar computing device that is operatively connected to surgical system 100 as described above. Data processing system 1600 may be configured to transmit and receive information related to a patient and/or a surgical plan associated with surgical system 100, for example.

In the depicted example, data processing system 1600 may employ a hub architecture including a north bridge and memory controller hub (NB/MCH)1601 and a south bridge and input/output (I/O) controller hub (SB/ICH) 1602. Processing unit 1603, main memory 1604, and graphics processor 1605 may be connected to NB/MCH 1601. Graphics processor 1605 may be connected to NB/MCH 1601 by, for example, an Accelerated Graphics Port (AGP).

In the depicted example, network adapter 1606 connects to SB/ICH 1602. Audio adapter 1607, keyboard and mouse adapter 1608, modem 1609, Read Only Memory (ROM)1610, Hard Disk Drive (HDD)1611, optical drive (e.g., CD or DVD)1612, Universal Serial Bus (USB) ports and other communication ports 1613, and PCI/PCIe devices 1614 may be connected to SB/ICH 1602 by bus system 1616. PCI/PCIe devices 1614 may include Ethernet adapters, add-in cards, and PC cards for notebook computers. ROM 1610 may be, for example, a flash basic input/output system (BIOS). The HDD 1611 and the optical drive 1612 may use an Integrated Drive Electronics (IDE) or Serial Advanced Technology Attachment (SATA) interface. A super I/O (SIO) device 1615 may be connected to SB/ICH 1602.

An operating system may run on processing unit 1603. An operating system may coordinate and provide control of various components within data processing system 1600. As a client, the operating system may be a commercially available operating system. For example Java^TMAn object oriented programming system, such as programming system, may run in conjunction with the operating system and from an object oriented program or application executing on data processing system 1600 to an operating systemA system provisioning call is made. As a server, data processing system 1600 may be running a high-level interactive Executive operating system or Linux operating system

eServer^TMSystem

Data processing system 1600 may be a Symmetric Multiprocessor (SMP) system, which may include a plurality of processors in processing unit 1603. Alternatively, a single processor system may be employed.

Instructions for the operating system, the object-oriented programming system, and applications or programs are located on storage devices, such as HDD 1611, and are loaded into main memory 1604 for execution by processing unit 1603. The processes of the embodiments described herein may be performed by processing unit 1603 using computer usable program code, which may be located in a memory, such as main memory 1604, ROM 1610, or in one or more peripheral devices.

The bus system 1616 may be comprised of one or more buses. The bus system 1616 may be implemented using any type of communications fabric or architecture that provides for a transfer of data between different components or devices attached to the fabric or architecture. A communication unit, such as modem 1609 or network adapter 1606, may include one or more devices that may be used to transmit and receive data.

Those of ordinary skill in the art will appreciate that the hardware depicted in FIG. 16 may vary depending on the implementation. Other internal hardware or peripheral devices, such as flash memory, equivalent non-volatile memory, or optical disk drives and the like, may be used in addition to or in place of the hardware depicted. Moreover, the data processing system 1600 may take the form of any of a number of different data processing systems including, but not limited to, client computing devices, server computing devices, a tablet computer, laptop computer, telephone or other communication device, personal digital assistant, or the like. Essentially, data processing system 1600 may be any known or later developed data processing system without architectural limitation.

Although various illustrative embodiments incorporating the principles of the present teachings have been disclosed, the present teachings are not limited to the disclosed embodiments. Rather, this application is intended to cover any variations, uses, or adaptations of the present teachings and to use the general principles thereof. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which these teachings pertain.

In the foregoing detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, like reference numerals generally identify like parts, unless context dictates otherwise. The illustrative embodiments described in this disclosure are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that the various features of the present disclosure, as generally described herein, and illustrated in the figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are explicitly contemplated herein.

The present disclosure is not limited to the particular embodiment aspects described in this application, which are intended as illustrations of various features. Many modifications and variations may be made without departing from the spirit or scope as will be apparent to those skilled in the art. Functionally equivalent methods and devices (in addition to those enumerated herein) within the scope of the present disclosure will be apparent to those skilled in the art from the foregoing description. It is to be understood that this disclosure is not limited to particular methods, reagents, compounds, compositions, or biological systems, which can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

With respect to the use of substantially any plural and/or singular terms herein, those having skill in the art can translate from the plural to the singular and/or from the singular to the plural as is appropriate to the context and/or application. Various singular/plural permutations may be expressly set forth herein for the sake of clarity.

It will be understood by those within the art that, in general, terms used herein are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but is not limited to," etc.). Although the various compositions, methods, and devices are described in terms of "comprising" various components or steps (which are to be interpreted as meaning "including, but not limited to"), the compositions, methods, and devices can also "consist essentially of" or "consist of" the various components and steps, and such terms should be interpreted as defining a substantially closed set of components.

In addition, even if a specific number is explicitly recited, those skilled in the art will recognize that such recitation should be interpreted to mean at least the recited number (e.g., the bare recitation of "two recitations," without other modifiers, means at least two recitations, or two or more recitations). Further, in those instances where a term similar to "at least one of A, B and C" is used, in general, such a configuration is intended that a person of ordinary skill in the art will understand the meaning of the term (e.g., "a system having at least one of A, B and C" will include, but not be limited to, systems that have a alone, B alone, C alone, a and B together, a and C together, B and C together, and/or A, B and C together, etc.). In those instances where a term similar to "A, B or at least one of C, etc." is used, in general such a construction is intended that a meaning for the term will be understood by those skilled in the art (e.g., "a system having at least one of A, B or C" will include, but not be limited to, systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B and C together, etc.). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, like embodiments, or in the drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase "a or B" will be understood to include the possibility of "a" or "B" or "a and B".

In addition, where features of the disclosure are described in terms of markush groups, those skilled in the art will recognize that the disclosure is also described in terms of any individual member or subgroup of members of the markush group.

Those skilled in the art will appreciate that for any and all purposes, such as in terms of providing a written description, all ranges disclosed herein also encompass any and all possible subranges and combinations of subranges thereof. Any listed range can be easily considered as a full description and achieves the same range broken down into at least equal halves, thirds, quarters, fifths, tenths, etc. As a non-limiting example, each range discussed herein may be readily broken down into a lower third, a middle third, and an upper third, among others. Those skilled in the art will also appreciate that all language such as "up to," "at least," and the like includes the recited number and refers to ranges that can subsequently be broken down into subranges as described above. Finally, those skilled in the art will understand that a range includes each individual member. Thus, for example, a group having 1-3 cells refers to a group having 1, 2, or 3 cells. Similarly, a group having 1-5 cells refers to a group having 1, 2, 3, 4, or 5 cells, and so forth.

As used herein, the word "about" refers to a change in a numerical quantity, such as may occur through measurement or processing procedures in the real world; by inadvertent error occurrence in these procedures; by differences in the purity of the manufacture, source or composition or reagents; and so on. Generally, the word "about" as used herein means 1/10 that is greater or less than the stated value, e.g., ± 10%, of the ratio or range of values. The word "about" also refers to variations that would be considered equivalent by a person of ordinary skill in the art, provided such variations do not encompass known values of prior art practice. Each value or range of values after the term "about" is also intended to encompass the recited embodiments of absolute values or ranges of values. Quantitative values stated in this disclosure include equivalents to the stated value, whether modified by the word "about" or not, e.g., variations in the numerical quantity of such value that may occur but which are equivalents will be recognized by those skilled in the art.

The various features and functions disclosed above, as well as alternatives thereof, may be combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art, each of which is also intended to be encompassed by the disclosed embodiments.

Claims (20)

1. An apparatus for use during a surgical procedure, the apparatus comprising:

a body having a top portion;

an insertion tool operatively coupled to the top portion of the body, the insertion tool having at least one prong; and

a force indicator module configured to measure the applied one or more forces.

2. The device of claim 1, wherein the body is configured to house control circuitry operatively coupled to a strain gauge, a battery, and a wireless antenna.

3. The apparatus of claim 2, wherein the strain gauge comprises a sensor selected from the group consisting of: piezoelectric effect sensors, hall effect sensors, and inductive sensors.

4. The apparatus of any of claims 2-3, wherein the force indicator module comprises a display in communication with at least one strain gauge.

5. The device of any of claims 2-4, further comprising a robotic surgical system in communication with the wireless antenna.

6. The device of any one of claims 2-5, wherein the strain gauge is configured to record a measurement selected from the group consisting of: a minimum force measurement, a maximum force measurement, and combinations thereof.

7. The apparatus of claim 6, wherein the measurement is recorded based on one or more received triggers, wherein the one or more received triggers are selected from the group consisting of: user input, user gesture, user voice, time component, determined applied force, applied rotational force, and sensor input.

8. The apparatus according to any one of claims 1-7, wherein the insertion tool further comprises a tongue arrangement having a first long side, a second long side, a first short side and a second short side, the tongue arrangement being connected to the body only on the first short side; and is

Wherein the tongue is parallel to the body when no force is applied to the body, and wherein the tongue is configured to be displaced from the body at an angle when a magnitude of force is applied to a portion of the body.

9. The device of claim 8, wherein the angle is proportional to a force applied to the portion of the body.

10. The apparatus of any of claims 1-9, wherein the force indicator module is an analog meter comprising at least one marker corresponding to at least one force measurement, and wherein the tongue is configured to act as a pointer to the analog meter when a force is applied to a portion of the body.

11. The device of any one of claims 1-10, wherein the insertion tool is at least one of a z-type retractor and a huffman-type retractor.

12. A system for use during a surgical procedure, the system comprising:

an apparatus, the apparatus comprising:

a body having a top portion and including a strain gauge and a control circuit;

an insertion tool operatively coupled to the top portion of the body, the insertion tool having at least one prong; and

a force indicator module, wherein the force indicator module is configured to measure one or more applied forces; and

a robotic surgical system in communication with the control circuit.

13. The system of claim 12, wherein the strain gauge comprises a sensor selected from the group consisting of: piezoelectric effect sensors, hall effect sensors, and inductive sensors.

14. The system of any of claims 112-13, wherein the force indicator module comprises a display in communication with the at least one strain gauge.

15. The system of any one of claims 12-14, wherein the strain gauge is configured to record a measurement selected from the group consisting of: a minimum force measurement, a maximum force measurement, and combinations thereof.

16. The system of claim 15, wherein the measurement value is recorded based on one or more received triggers.

17. The system of claim 16, wherein the one or more received triggers are selected from the group consisting of: user input, user gesture, user voice, time component, determined applied force, applied rotational force, and sensor input.

18. The system according to any one of claims 12-17, wherein the insertion tool further comprises a tongue arrangement having a first long side, a second long side, a first short side and a second short side, the tongue arrangement being connected to the body only on the first short side; and is

Wherein the tongue is parallel to the body when no force is applied to the body, and wherein the tongue is configured to be displaced from the body at an angle when a magnitude of force is applied to a portion of the body.

19. The system of claim 18, wherein the angle is proportional to a force applied to the portion of the body.

20. The system of any of claims 12-19, wherein the force indicator module is an analog meter comprising at least one marker corresponding to at least one force measurement, and wherein the tongue is configured to act as a pointer to the analog meter when a force is applied to a portion of the body.

Images